DSG A5 book 2

First edition, June 2019.

This book was written by the Bio-Oil research and development team for
skincare professionals. The information pertaining to the physiology of the skin is
not intended to replace academic texts or to provide medical advice.



Table of contents 1

1. Introduction 2

2. Understanding dry skin 2
2
2.1. Structure of the skin 2
2.2. How the skin controls its moisture levels 2
2.2.1. Lipid bilayer 2
2.2.2. Natural moisturising factor 2
2.3. Dry skin symptoms 2
2.4. Dry skin causes 3
2.4.1. External factors 3
2.4.2. Internal factors 3
2.5. Dry skin treatments 3
2.5.1. How occlusion works
2.5.2. How humectancy works 4

3. Research and development 4
4
3.1. Observation 4
3.2. Current dry skin products 4
3.3. Criticism of current dry skin products 5
3.4. Opportunity for a new dry skin product 5
3.5. Gel - a new way to treat dry skin
3.6. Emulsions vs Bio-Oil Dry Skin Gel 6

4. Formulation 6
7
4.1. Ingredient declaration 9
4.2. Ingredients explained 9
4.3. Occlusive phase ingredients 10
4.3.1. Mineral oil 10
4.3.2. Isopropyl Palmitate 10
4.3.3. Triisononanoin 10
4.3.4. PurCellin Oil™ 11
4.3.5. Caprylic/Capric Triglyceride
4.3.6. Isostearyl Isostearate

4.3.7. Isopropyl Myristate 11
4.3.8. Shea butter 11
4.3.9. Lanolin 11
4.3.10. C26-28 Alkyl Dimethicone 12

4.4. Humectant ingredients 12
4.4.1. Urea 12
4.4.2. Glycerin 12
4.4.3. Hyaluronic acid 13
4.4.4. Lactic acid 13
4.4.5. Sodium Lactate 13
4.4.6. Sodium PCA 13
4.4.7. Butylene Glycol 13
4.4.8. Gluconolactone 13

4.5. Barrier repair and maintenance ingredients 14
4.5.1. Vitamin A 14
4.5.2. Vitamin B3 15
4.5.3. Vitamin E 15
4.5.4. Vitamin F 16
4.5.5. Rosemary oil 16
4.5.6. Lavender oil 16
4.5.7. Chamomile oil 16
4.5.8. Calendula oil 17
4.5.9. Pseudo-Ceramide 17
4.5.10. Bisabolol 17
4.5.11. Dimethicone/vinyl Dimethicone Crosspolymer 18

4.6. Other ingredients 18
4.6.1. Silica 18
4.6.2. Water 18
4.6.3. Sucrose Laurate and Sucrose Stearate 18
4.6.4. Tocopherol 19
4.6.5. BHT 19
4.6.6. Fragrance 19
4.6.7. Allergens 19
4.6.8. Colourant 20

4.7. Safety assessment 20

5. Testing 21

5.1. Moisture efficacy clinical trial 21

5.2. Dry skin user trial 22

5.3. Derma tests 23
5.3.1. Sensitive skin test 23

5.3.2. Non-comedogenic study 23
5.3.3. Occlusivity study 24

6. Manufacture 25

6.1. GMP certification 25
6.2. Raw materials 25
6.3. Packaging materials 25
6.4. Mixing, filling and packing quality controls 25
6.5. Batch numbers and retention samples 26
6.6. No harmful substances generated 26

7. Application 27

7.1. How to apply 27
7.2. How long to use 27
7.3. Use in conjunction with a skincare routine 27
7.4. Use on babies 27
7.5. Use during pregnancy and breastfeeding 27
7.6. Use in the sun 28
7.7. Use on or near mucosal membranes 28
7.8. Use with various skin types 28
7.8.1. Sensitive skin 28
7.8.2. Oily skin 28
7.9. Use with various skin conditions 28
7.9.1. Acne-prone skin 28
7.9.2. Psoriasis 28
7.9.3. Eczema 29
7.10. Accidental ingestion 29
7.11. Removing from clothing 29

8. Adverse reactions 30

8.1. Causes of adverse reactions 30
8.1.1. Allergens 30
8.1.2. Hormonal changes 30

8.2. Typical symptoms of an adverse reaction 30
8.3. What to do in the event of an adverse reaction 30
8.4. Conducting a simple allergy test 31
8.5. Record of adverse reactions 31

9. Packaging 32

9.1. Description 32
9.2. Brand name 32
9.3. Pack sizes 32
9.4. Materials 33
9.5. Packaging symbols 34

10. Other information 36

10.1. Not tested on animals 36
10.2. Veganism 36
10.3. Use of natural ingredients 36
10.4. Soy allergens 36
10.5. Palm oil 36
10.6. Extreme temperatures 37
10.7. REACH registration 37
10.8. Nanotechnology 37
10.9. Does not contain 37
10.9.1. Preservatives 37
10.9.2. Parabens 37
10.9.3. Phthalates 37
10.9.4. Food allergens 38

11. Glossary of terms 39





1. Introduction

Bio-Oil® Dry Skin Gel is the next generation in the treatment of dry skin. It
improves on the existing dry skin technology of creams, lotions and body butters
by replacing the in-active water in these formulations with oil, resulting in a
product that is 100% active in treating dry skin. The formulation is delivered in a
breakthrough new gel format.

1

2. Understanding dry skin

2.1. Structure of the skin

The skin is made up of the dermis, located deep within the skin, and the
epidermis on the surface. The uppermost part of the epidermis is the stratum
corneum which contains the skin’s natural oily layer, known as the lipid bilayer.

2.2. How the skin controls its moisture levels

The skin has two primary mechanisms for controlling its moisture levels.

2.2.1. Lipid bilayer
The skin’s moisture comes from within, rises up through the skin and escapes
into the outside air in a process known as transepidermal water loss (TEWL).
The lipid bilayer controls how much moisture escapes and how much moisture is
held in the skin.

2.2.2. Natural moisturising factor
The skin produces natural moisturising factor (NMF)1 that attracts and binds
moisture in its immediate environment, holding moisture in the skin.

2.3. Dry skin symptoms

Symptoms of dry skin include dull and flaky skin, peeling, inflammation, fine lines
or cracks, grey or ashy coloured skin and the feeling of roughness and tightness.

2.4. Dry skin causes

Dry skin is caused by both external and internal factors.

2.4.1. External factors
- Dry climates cause moisture to be drawn from inside the skin, through the lipid

bilayer, and into the dry outside air.
- Air conditioners and heaters draw moisture out of the air, creating an artificially

dry climate which draws moisture out of the skin.
- Everyday washing and exposure to harsh detergents cause the skin’s lipid

bilayer to be stripped, making it easier for moisture to escape from the skin.

1. NMF is a group of substances made up of amino acids, pyrrolidine carboxylic acid (PCA), inorganic
salts, natural sugars, lactates and urea.

2

2.4.2. Internal factors

- As the body ages, the skin produces fewer lipids causing the lipid bilayer to
thin and making it easier for moisture to escape.

- Genetics can play a role in the development of dry skin due to naturally
occurring lower levels of ceramides in the lipid bilayer. This results in reduced
occlusivity of the skin barrier, contributing to above normal levels of moisture
escaping.

- The pH of the skin2 influences the barrier function. A higher pH level in the skin
impairs the healthy functioning of the lipid bilayer.

2.5. Dry skin treatments

There are two principle ways to treat dry skin. The first is to apply an occlusive
substance – such as oil, butter or wax – to the surface of the skin to prevent
moisture loss. The second is to apply humectant ingredients to the skin that
attract and bind water. Of the two ways to remedy dry skin, occlusion is
considered the superior option.

2.5.1. How occlusion works

Occlusive ingredients mimic the function of the skin’s lipid bilayer. The best way
to understand how occlusion works in dry skin is through an experiment. Take
two beakers of water and add oil to one of the beakers. The oil will rise to the top
and sit on the surface of the water. Over time, the water in the beaker without
the oil will evaporate, while the oil-covered water in the other beaker will stay at
the same level.

2.5.2. How humectancy works

Humectant ingredients are used to mimic the function of NMF. Like NMF,
humectants attract and bind moisture in their immediate environment, providing
skin-hydrating benefits.

2. Solutions are measured on a pH scale 0 – 14. Acidic solutions have a lower pH whereas more
alkaline solutions have a high pH. pH neutral is a solution with a pH of 7. The optimal pH of the skin
is a pH of 5.5.

3

3. Research and development

3.1. Observation

There are billions of dry skin sufferers across the globe, many of whom use a dry
skin product on a regular basis. Dry skin continues however to be the biggest
unmet need in skincare and so it must be assumed that dry skin products are
not meeting the needs of dry skin sufferers.

3.2. Current dry skin products

Typically, dry skin is treated using creams, lotions and body butters. These
products are known as emulsions. Emulsions are made by combining oil and
water using an emulsifier, to create a product which is white, fluffy, light and easy
to apply. The invention of emulsions over a hundred years ago led to exponential
growth in the use of dry skin products. Not only were these products visually
appealing and easy to use compared to the greasy oils that came before, but
because they were made primarily from water, they were also substantially
cheaper to produce.

Emulsions work in two ways. The oil in the product creates an occlusive barrier
on the skin which helps the skin hold in its moisture. Humectants are mixed
into the water part of the emulsion and on application get absorbed into the
skin, attracting and binding moisture in their immediate environment, creating a
moisturising effect. Humectants are mixed into the water part of an emulsion as
they do not dissolve in oil.

3.3. Criticism of current dry skin products

For all their success, emulsions ignore the fact that skin is hydrophobic (water-
hating) and repels water. Even so, the average emulsion is still made with around
70% water.

This means that when you use an emulsion most of it (the water part) simply
evaporates when coming into contact with your skin and is inactive in treating
dry skin. This evaporation is what causes a cold sensation when applying a
cream and is why creams were originally called cold creams.

3.4. Opportunity for a new dry skin product

Given that emulsions are predominantly inactive in treating dry skin, an
opportunity existed to try make them more active by removing the inactive water
and replacing it with oil. However, removing the water completely was not an
option because humectants, many of which are powders, only dissolve in water.

4

So the question became, how much water is needed to dissolve humectants?
The answer we discovered was 3% – substantially less than the 70% used in the
average emulsion. The challenge then became how to formulate a product made
predominantly with oil and only 3% water.

3.5. Gel - a new way to treat dry skin

Technically, it is very difficult to make a product predominantly of oil and only 3%
water. The answer lay in creating a gel. Bio-Oil Dry Skin Gel is made with 87%
oil, 10% humectants and 3% water.

3.6. Emulsions vs Bio-Oil Dry Skin Gel

The diagram below compares the ingredient makeup of typical emulsions to
Bio-Oil Dry Skin Gel. The percentages used for the emulsions are estimates.

20% oils, butters 87% oils, butters
and waxes and waxes
10% humectants

70% water

10% humectants
3% water

Emulsions Bio-Oil® Dry Skin Gel

5

4. Formulation

4.1. Ingredient declaration

Below is INCI listing as it appears on Bio-Oil Dry Skin Gel’s packaging.3
Paraffinum Liquidum, Isopropyl Palmitate, Triisononanoin, Cetearyl
Ethylhexanoate, Glycerin, Butyrospermum Parkii Butter, Aqua, Isopropyl
Myristate, Urea, Caprylic/Capric Triglyceride, Isostearyl Isostearate, C26-28
Alkyl Dimethicone, Sodium Lactate, Gluconolactone, Sodium PCA, Sodium
Hyaluronate, Octyldodecyl PCA, Sucrose Laurate, Sucrose Stearate, Lactic
Acid, Lanolin, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer,
Bisabolol, Helianthus Annuus Seed Oil, Silica, Glycine Soja Oil, BHT, Retinyl
Palmitate, Tocopheryl Acetate, Niacinamide, Linoleic Acid, Linolenic Acid,
Tocopherol, Anthemis Nobilis Flower Oil, Calendula Officinalis Extract,
Rosmarinus Officinalis Leaf Oil, Lavandula Angustifolia Oil, Parfum, Citronellol,
Farnesol, Limonene, Linalool, CI 17200.

3. The International Nomenclature of Cosmetic Ingredients (INCI) is an international system for the
standardised naming of cosmetic ingredients. The system was initially promulgated and adopted by
regulatory authorities in the US, EU and Japan, and therefore makes allowance for some variances
in nomenclature (example, in the naming of botanicals and colourants). INCI names are mandated
to appear on the outer product packaging of every personal care product. This enables consumers
to identify any ingredients to which they may be allergic. INCI protocol requires that all ingredients
in a product formulation must be listed. Those ingredients whose inclusion is greater than 1% of the
formulation should be listed from highest to lowest percentage. Ingredients whose inclusion is less
than 1% can be listed in any order. The exact quantity of each ingredient is kept confidential.

6

4.2. Ingredients explained

The ingredient listing is categorised into occlusive ingredients, humectant
ingredients, barrier repair and maintenance ingredients, and other ingredients.
Both the European and US INCI names are shown.

Ingredient Ingredient INCI name INCI name
category (European) (US)
Mineral oil
Occlusive phase Paraffinum Paraffinum
ingredients Isopropyl Palmitate Liquidum Liquidum (Mineral
Triisononanoin Oil)
PurCellin Oil™ Isopropyl Palmitate
Isopropyl Palmitate
Caprylic/Capric Triisononanoin
Triglyceride Triisononanoin
Isostearyl Cetearyl
Isostearate Ethylhexanoate Cetearyl
Isopropyl Myristate Ethylhexanoate
Shea butter Isopropyl Myristate
Isopropyl Myristate
Lanolin Caprylic/Capric
C26-28 Alkyl Triglyceride Caprylic/Capric
Dimethicone Triglyceride
Isostearyl
Isostearate Isostearyl
Isostearate
Isopropyl Myristate
Isopropyl Myristate
Butyrospermum
Parkii Butter Butyrospermum
Parkii (Shea) Butter
Lanolin
Lanolin
C26-28 Alkyl
Dimethicone C26-28 Alkyl
Dimethicone

Humectant phase Urea Urea Urea
ingredients Glycerin
Hyaluronic acid Glycerin Glycerin

Sodium Sodium
Hyaluronate Hyaluronate

Lactic acid Lactic Acid Lactic Acid
Sodium Lactate Sodium Lactate Sodium Lactate
Sodium PCA Sodium PCA Sodium PCA
Butylene Glycol Butylene Glycol Butylene Glycol
Gluconolactone Gluconolactone Gluconolactone

7

Ingredient Ingredient INCI name INCI name
category Vitamin A (European) (US)
Retinyl Palmitate
Barrier repair and Vitamin B3 Helianthus Annuus Retinyl Palmitate
maintenance Vitamin E Seed Oil
Vitamin F Helianthus Annuus
Niacinamide (Sunflower) Seed
Rosemary oil Tocopheryl Acetate Oil
Linoleic Acid
Lavender oil Linolenic Acid Niacinamide
Rosmarinus
Chamomile oil Officinalis Leaf Oil Tocopheryl Acetate
Calendula extract
Lavandula Linoleic Acid
Pseudo-Ceramide Angustifolia Oil
Bisabolol Linolenic Acid
Dimethicone/ Anthemis Nobilis
Vinyl Dimethicone Flower Oil Rosmarinus
Crosspolymer Calendula Officinalis
Officinalis Extract (Rosemary) Leaf Oil
Glycine Soja Oil
Lavandula
Octyldodecyl PCA Angustifolia
Bisabolol (Lavender) Oil
Dimethicone/
Vinyl Dimethicone Anthemis Nobilis
Crosspolymer Flower Oil

Calendula
Officinalis Extract

Glycine Soja
(Soybean) Oil

Octyldodecyl PCA

Bisabolol

Dimethicone/
Vinyl Dimethicone
Crosspolymer

8

Ingredient Ingredient INCI name INCI name
category (European) (US)
Silica Silica Silica
Other ingredients Water Aqua Water/Aqua/Eau
Sucrose Laurate Sucrose Laurate Sucrose Laurate
Sucrose Stearate Sucrose Stearate Sucrose Stearate
Tocopherol Tocopherol Tocopherol
BHT BHT BHT
Fragrance Parfum Fragrance (Parfum)
Allergens Citronellol Citronellol
Farnesol Farnesol
Colourant Limonene Limonene
Linalool Linalool
CI 17200 Red 33 (CI 17200)

4.3. Occlusive phase ingredients

The use of occlusive ingredients is the gold standard in the treatment of dry
skin. Occlusive ingredients provide much needed relief from dry skin by locking
moisture into the skin. This is done through the application of an oily layer to
the skin which reduces TEWL. Occlusive ingredients work to coat the stratum
corneum thereby preventing unwanted water loss. This is the most effective way
to treat dry skin.

4.3.1. Mineral oil

Pharmaceutical grade mineral oil4 – known in the INCI list as Paraffinum Liquidum
– is included in the formulation for its occlusive properties. Mineral oil forms
a protective film on the outer layer of the skin, preventing TEWL and locking
moisture in. Mineral oil also acts as a delivery vehicle for the formulation oil-
soluble vitamins and plant extracts.

Mineral oil is widely used in cosmetic products, but its source as a so-called
‘by -product’ of petroleum is the subject of much misinformation. In reality,
pharmaceutical grade mineral oil, as used in Bio-Oil Dry Skin Gel, is a specifically

4. Pharmaceutical grade mineral oil complies with the British, European and United States of America
Pharmacopoeias.

9

isolated and highly purified fraction of petroleum, with very specialised product
applications and an excellent record of safety.

4.3.2. Isopropyl Palmitate
Isopropyl Palmitate is an ester of isopropyl alcohol and palmitic acid, which
appears as a clear oily liquid.

Isopropyl Palmitate is a non-sticky oil which works as an occlusive lubricant in
Bio-Oil Dry Skin Gel. Isopropyl Palmitate also has skin smoothing properties
which help the formulation to be evenly spread.

4.3.3. Triisononanoin
Triisononanoin is a synthetic oil blend composed mainly of triglycerides
– materials that absorb rapidly into the skin’s surface. Triisononanoin is a
transparent, water-like liquid.

Triisononanoin migrates naturally to the narrow spaces between the surface skin
cells in the epidermis making it easily absorbed and effective as an occlusive
ingredient.

4.3.4. PurCellin Oil™
PurCellin Oil™ is a mixture of two ingredients, both of which are esters. Their
INCI names are Cetearyl Ethylhexanoate and Isopropyl Myristate.

PurCellin Oil™ exhibits spreading properties on the skin, producing a protective
film which is neither sticky nor greasy. It also reduces the thickness of the Bio-Oil
Dry Skin Gel formulation, making it readily absorbed.

PurCellin Oil™ further assists in maintaining the natural water vapour permeability
of the skin, thus allowing it to ‘breathe’ properly and maintain its normal
physiology.

4.3.5. Caprylic/Capric Triglyceride
Caprylic/Capric Triglyceride is a natural derivative of coconut oil which is
combined with glycerine5 to deliver a lightly-textured, clear, odourless and non-
greasy oil.

Caprylic/Capric Triglyce is included in Bio-Oil Dry Skin Gel for its occlusive
properties. The liquid provides a light-weight and non-greasy barrier of lubrication
to the skin.

5. Glycerine, glycerin and glycol are used interchangeably in cosmetics formulations. Glycerine is used
to describe the ingredient; glycerin is the INCI name and glycol is the name frequently used in the
medical fraternity.

10

4.3.6. Isostearyl Isostearate
Isostearyl Isostearate is an ester of isostearyl alcohol and isostearic acid (found in
rapeseed oil). The source of Isostearyl Isostearate used in Bio-Oil Dry Skin Gel is
free from genetically modified organisms (GMOs).

Isostearyl Isostearate is used in Bio-Oil Dry Skin Gel to lock moisture into the
skin. Isostearyl Isostearate has skin conditioning and moisturising properties
through the forming of a film on the skin. Clinical studies show that Isostearyl
Isostearate is effective in reducing TEWL.

4.3.7. Isopropyl Myristate
Isopropyl Myristate is an ester of isopropyl alcohol and myristic acid (a naturally
occurring fatty acid).

Isopropyl Myristate has the unique ability to not only form a barrier to control
water loss, but also to reduce the greasy feel often associated with oils, thereby
making the formulation ‘skin-friendly’. Isopropyl Myristate is easily absorbed into
the skin, ensuring the rapid penetration of the formulation ingredients. Isopropyl
Myristate helps makes Bio-Oil Dry Skin Gel feel non-greasy and light.

4.3.8. Shea butter
Shea butter is a semi-solid, light yellowish fat derived from the leaves of the
African Shea tree.

Shea butter is a waxy substance which forms a barrier to retain moisture and
reduce TEWL in the skin. The moisturising fats found in shea butter mimic those
produced by the sebaceous glands of the skin.

4.3.9. Lanolin
Lanolin is an ointment-like material isolated from sheep’s wool. Lanolin is
secreted by the sebaceous glands of sheep to produce a yellow and waxy
substance. Lanolin is free of glycerides, making it a wax and not a fat. The
source of Lanolin in Bio-Oil Dry Skin Gel is ultra-pure medical grade.

Lanolin is packed with ceramides which are naturally found in the skin. As a
result, Lanolin is an exceptional moisturiser and natural occlusive, acting almost
like a second skin and playing a major role in the reinforcement of the skin’s
natural lipid barrier function. Lanolin lubricates the skin to give a soft and smooth
appearance, preventing the evaporation of water and providing prolonged
moisturising benefits.

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4.3.10. C26-28 Alkyl Dimethicone
C26-28 Alkyl Dimethicone is a synthetic silicone resin, which appears as a
cream-coloured waxy substance.

C26-28 Alkyl Dimethicone is used in Bio-Oil Dry Skin Gel for its ability to provide
occlusivity and for its skin spreading properties. C26-28 Alkyl Dimethicone forms
a film on the skin which also helps to prevent the loss of moisture, in addition to
making the skin feel silky smooth.

4.4. Humectant ingredients

After occlusive ingredients, humectant ingredients – generally called humectants
– are the next best way to treat dry skin. Humectants are water-soluble materials
which act like mini sponges, attracting and holding water from the immediate
environment to provide deep hydration.

4.4.1. Urea
Urea is a crystalline compound derived from ammonia and carbon dioxide,
yielding a coarse powder.

Urea’s role within the skin is to maintain a healthy moisture balance by attracting
water, keeping skin soft and supple and bringing much needed relief to dry skin.
Urea is one of the major components of the skin’s NMF.6

4.4.2. Glycerin
Glycerin7 is a naturally occurring fatty acid that is derived from palm and palm
kernel oil. The source of Glycerin used in Bio-Oil Dry Skin Gel is free from GMOs.

Glycerin is the gold standard in humectancy. Glycerin deeply hydrates the
stratum corneum by allowing this layer of the skin to retain high levels of water,
even in particularly dry climates. This reduces the evaporation rate of moisture
from the skin’s surface. Not only is it extremely effective in the treatment of dry
skin conditions, but new research indicates that glycerine also has a repairing
action on the skin barrier.

Glycerin also has a keratolytic effect and helps with desquamation, the skin’s
natural exfoliating process that breaks down skin cells, preventing dull, flaky
skin. With the level of Glycerin used in Bio-Oil Dry Skin Gel, one would expect
the formulation to have a tacky and sticky feel. However, through the inclusion
of silicone dispersed in the external water phase, the formulation has a light and
non-greasy feel both on application and post absorption.

6. Urea is approximately 7% of NMF.
7. Glycerine, glycerin and glycol are used interchangeably in cosmetics formulations. Glycerine is used

to describe the ingredient; glycerin is the INCI name and glycol is the name frequently used in the
medical fraternity.

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4.4.3. Hyaluronic acid
Sodium Hyaluronate – the INCI name for hyaluronic acid – is a bioavailable form
of hyaluronic acid, produced as a fine powder.

Hyaluronic acid is a powerful water-binding ingredient that has the ability to
penetrate deep spaces between connective fibres such as collagen and elastin,
offering moisturising benefits. Hyaluronic acid attracts water and has the ability
to bind over 1000 times its weight in water, thus providing a plumping and
cushioning skin effect.

4.4.4. Lactic acid
Lactic acid is a water-soluble liquid produced through the fermentation process
of natural carbon sources, such as sugar, starch or carbohydrates.

Lactic acid is both an alpha hydroxy acid (AHA) as well as a component of NMF.
As a result, lactic acid has the unique ability to gently exfoliate the skin whilst
working to soften and hydrate by binding moisture.

4.4.5. Sodium Lactate
Sodium Lactate is the sodium salt of lactic acid which is combined with water to
produce a water-soluble liquid.

In Bio-Oil Dry Skin Gel, Sodium Lactate has a skin moisturising effect through its
water binding properties. Sodium Lactate also improves the overall feel of the gel
on the skin.

4.4.6. Sodium PCA
Sodium PCA is a synthetically derived sodium salt. PCA stands for Pyrrolidine
Carboxylic Acid.

Sodium PCA is another constituent of NMF. It is widely used in cosmetics for its
ability to mimic the skin’s natural ability to hold and absorb moisture and provide
deep levels of moisturisation.

4.4.7. Butylene Glycol
Butylene Glycol is an organic glycol which comes in the form of a thick and oily
liquid.

Butylene Glycol acts primarily as a humectant to attract water to the skin.
Butylene Glycol works in Bio-Oil Dry Skin Gel to enable the formulation to be
rapidly absorbed and to provide skin conditioning benefits.

4.4.8. Gluconolactone
Gluconolactone is a white crystalised powder made through the process of

13

fermentation of gluconic acid.
Gluconolactone is a polyhydroxy acid (PHA) which gently exfoliates
dead skin cells on the surface, resulting in even skin tone and healthy skin
texture.

4.5. Barrier repair and maintenance ingredients

In addition to occlusive and humectant phase ingredients, a number of other
ingredients are included in the Bio-Oil Dry Skin Gel formulation to maintain
the integrity and health of the lipid bilayer. Ingredients for barrier repair and
maintenance are included to mimic the nature-identical functioning of the lipid
bilayer, which is responsible for maintaining healthy moisture content in the skin.

4.5.1. Vitamin A
Retinol is a naturally occurring form of vitamin A. To prevent oxidisation, retinol
goes through an esterification process with palmitic acid for its use in Bio-Oil Dry
Skin Gel. The resulting ester is commonly referred to as Vitamin A Palmitate (or
Retinyl Palmitate).
The Vitamin A Palmitate is immersed in sunflower seed oil to dilute its
concentration and deliver it in an appropriate form for skin absorption. This
accounts for the presence of sunflower seed oil in the Bio-Oil Dry Skin Gel
formulation. The INCI names are Retinyl Palmitate and Helianthus Annuus Seed
Oil.
Vitamin A Palmitate demonstrates skin renewing properties. It increases the
thickness of the epidermis, particularly in mature skin types, and promotes the
formation of new collagen. Vitamin A Palmitate improves the appearance of UV-
damaged skin, by helping to increase elasticity and smooth the appearance of
fine lines and wrinkles.
Sunflower seed oil improves the texture and smoothness of the skin. In Bio-Oil
Dry Skin Gel, it is used primarily as a delivery vehicle for Retinyl Palmitate.
Consumers have on occasion expressed concern around the possible link
between Retinyl Palmitate and cancer. This is likely based on the preliminary data
released for a study conducted by the US Food and Drug Administration (FDA) in

14

2009. The study has subsequently been refuted based on flaws in the research.8

In 2010, the Journal of the American Academy of Dermatology (JAAD), found
that there was no conclusive evidence to link Retinyl Palmitate and skin cancer in
human skin.

4.5.2. Vitamin B3

Vitamin B3 is an essential vitamin of the B group and is a water-soluble vitamin,
naturally found in nutrient dense foods such as meat, fish, milk, eggs and green
vegetables. The form used in Bio-Oil Dry Skin Gel is known as niacinamide,
which is synthetically produced.

Vitamin B3 is included in the Bio-Oil Dry Skin Gel formulation as a building block
to strengthen the skin’s moisture barrier. Vitamin B3 works in the layers below
the stratum corneum to improve skin elasticity, creating a healthy skin tone and
texture. Long term use of vitamin B3 boosts the health of the epidermis and the
skin barrier function.

4.5.3. Vitamin E

Bio-Oil Dry Skin Gel contains a synthetic ester of vitamin E, commonly referred to
as Vitamin E Acetate. The INCI name is Tocopheryl Acetate.

Vitamin E has been scientifically proven to have a number of benefits to the skin.
The primary benefit is as an antioxidant. Antioxidants are essential in helping
to reduce free radicals which attack healthy cells and cause skin damage and
premature ageing.

Vitamin E also increases the moisture content of the epidermis, making it feel
softer and smoother. It mitigates against some of the effects of sunburn in that it
reduces the number of damaged cells found after skin has been exposed to UV
radiation. It has also been shown to have positive effects on the wound healing
process.

8. The FDA study data was used as the basis for a report by the Environmental Working Group (EWG),
which was published in July 2010. The report claimed that Retinyl Palmitate may increase the risk of
skin cancer forming when added to sun protection products. The primary concern of the EWG report
was that when Retinyl Palmitate is exposed to sunlight, it can increase the generation of free radicals
on the skin which could cause cell disruption and eventually skin cancer.

The Journal of the American Academy of Dermatology (JAAD) published a report in August 2010
refuting the findings of the EWG report. The JAAD report, conducted by Dr Steven Wang, Director of
Dermatologic Surgery at the Memorial-Sloan Kettering Cancer Centre in New York, found that there
was no conclusive evidence to suggest that Retinyl Palmitate and UVA radiation could cause an
increase in the rates of skin cancer on human skin.

The flaw in the EWG research is that it was based on non-human studies and was not representative
of the effects on human skin. Dr Wang has since commented that years of research suggest that
retinoids are actually helpful in reducing the risk of skin cancer.

15

4.5.4. Vitamin F
Vitamin F is the name commonly given to the oily liquid, derived from two fatty
acids found in the safflower plant. Their INCI names are Linoleic Acid and
Linolenic Acid – omegas 6 and 3 respectively – which are found naturally in the
oily layer of the skin.

Unlike other vitamins, vitamin F is better classified as a fat as a result of being
directly sourced from plant oils. Significantly, the Linoleic and Linolenic fatty acids
from which vitamin F is derived are essential for the normal functioning of healthy
skin cells. Vitamin F exhibits regenerative and metabolic properties, allowing the
synthesis and renewal of skin lipids in the lipid bilayer.

4.5.5. Rosemary oil
Rosemary oil is obtained by distilling the stems and leaves of the rosemary plant.
The INCI name is Rosmarinus Officinalis Leaf Oil.

Rosemary oil is used as a skin conditioning agent because of its soothing
properties and mild antiseptic capability.9

4.5.6. Lavender oil
Lavender oil is the natural plant oil derived from the flowers of the lavender plant.
The INCI name is Lavandula Angustifolia Oil.

Lavender oil has multiple benefits for the skin. It is known to have skin
conditioning properties such as improved firmness, smoothness and complexion.
It provides calming and soothing benefits coupled with mild astringency which
cleans the skin by constricting the pores, resulting in a tingling sensation. It is
also a natural antiseptic with the ability to kill many common bacterial species.

4.5.7. Chamomile oil
Chamomile oil is derived from the flowers of the Anthemis Nobilis, or Roman
Chamomile, plant. The INCI name is Anthemis Nobilis Flower Oil.

Chamomile oil is an anti-inflammatory, providing soothing and calming benefits
to the skin. It is effective where the skin is stressed by both internal and external
physiological conditions.

9. Rosemary oil is thought to be neurotoxic when ingested in excessive amounts. If taken orally it
may pose safety concerns for persons suffering from high blood pressure and epilepsy. However,
when topically applied to the skin, Rosemary oil has a very good safety profile. The American Board
of Toxicology conducted an independent toxicological assessment on Rosemary oil and found a
concentration of up to 5% to be safe for topical usage. Bio-Oil Dry Skin Gel has a concentration of
0.05% Rosemary oil and is therefore safe to use topically.

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4.5.8. Calendula oil

Calendula extract is derived from the blossoms of the marigold plant, which
are immersed in a soybean oil base. The oil is stabilised with an antioxidant to
ensure retention of the beneficial properties of the blossoms. The INCI name
for calendula extract is Calendula Officinalis Extract and the soybean oil base is
Glycine Soja Oil.

Calendula extract has cell regenerative effects and is suitable for the treatment
of sensitive, damaged or sunburnt skin. Calendula extract has also been used to
combat minor skin infections, rashes and superficial irritation.

Soybean oil has been used by the Chinese for more than 4,000 years and
is shown to have nutritional benefits on the skin, improving texture and
smoothness.

4.5.9. Pseudo-Ceramide

Pseudo-Ceramide is an oil-soluble salt of vegetable origin, dissolved in a
lipophilic liquid. Its INCI name is Octyldodecyl PCA. PCA stands for Pyrrolidine
Carboxylic Acid.

Pseudo-Ceramides have developed a well-deserved reputation for barrier repair
in facial skincare products. This is because Pseudo-Ceramides are made up
of waxy ceramides, which are lipids found naturally in the skin’s lipid layer.10
Ceramides provide not only a water-proof barrier in the upper layers of the skin,
but are also critical in maintaining and repairing the skin barrier.

4.5.10. Bisabolol

Bisabolol exists in two structural forms: alpha and beta. Alpha-Bisabolol is most
commonly used in cosmetic and personal care products and is the form used
in Bio-Oil Dry Skin Gel. Alpha-Bisabolol is a synthetic combination of the four
compounds of Bisabolol that occur in nature. The INCI name is Bisabolol.

Bisabolol is included in Bio-Oil Dry Skin Gel for its anti-inflammatory properties,
providing soothing and calming benefits to the skin. It is effective where the skin
is stressed by both internal and external physiological conditions. Bisabolol has
mild antibacterial properties, making it less susceptible to certain foreign bacteria
that may cause irritations and infections.

Bisabolol contains the allergen, Farnesol, which should be avoided by those with
a hypersensitivity to ragweed pollens.

10. Ceramides are one of the major components of the skin’s lipid bilayer. The word ceramide is derived
from the Latin word meaning wax.

17

4.5.11. Dimethicone/vinyl Dimethicone Crosspolymer
Dimethicone/vinyl Dimethicone Crosspolymer is a cross polymer powder, used in
the water phase of Bio-Oil Dry Skin Gel.

Dimethicone/vinyl Dimethicone Crosspolymer Silica is hydrophobic – or water
hating – and has film forming abilities which reduces TEWL. Dimethicone/vinyl
Dimethicone Crosspolymer also reduces the glossy shine in the formulation
traditionally associated with oils.

4.6. Other ingredients

A number of other ingredients are included in the Bio-Oil Dry Skin Gel
formulation for purposes other than occlusivity, humectancy or barrier repair and
maintenance. These include ingredients that add to the smooth and non-sticky
feel of the gel on application, emulsifiers that act to mix the oil and water phases,
water to dissolve the humectants, antioxidants to preserve the formulation, and
the formulation fragrance and colour.

4.6.1. Silica
Silica is a fine powder formed of natural sand deposits. The grade of silica used
in Bio-Oil Dry Skin Gel is not classified as a nanomaterial.

Silica enables Bio-Oil Dry Skin Gel to have a non-sticky and non-tacky feel.
Silica works with the other formulation ingredients to provide a smooth, light and
powdery texture when applying the gel.

4.6.2. Water
The water that is used in the Bio-Oil Dry Skin Gel formulation is highly purified
to ensure that its quality is consistent, whilst ensuring the delivery of maximum
efficacy of the product.

Less than 3% of the total Bio-Oil Dry Skin Gel formulation is purified water. There
is water present in the Sodium Lactate and Sodium PCA as well as the specialist
emulsifier. In addition, a very small amount of water is included in the formulation
to dissolve the humectants. With the formulation being so low on water, users
will never experience the cold feel on application that is typically asossiated with
traditional skin creams.

4.6.3. Sucrose Laurate and Sucrose Stearate
Both Sucrose Laurate and Sucrose Stearate are fine white powders, derived
from natural sugars such as sugar cane.

Sucrose Laurate and Sucrose Stearate work together as completely natural
emulsifiers in the formulation, actively binding the oil and water phases.

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4.6.4. Tocopherol

Tocopherol is a high-purity grade synthetic antioxidant. The Tocopherol used in
Bio-Oil Dry Skin Gel is dl-alpha-tocopherol.

As an antioxidant, Tocopherol has the effect of preserving the shelf-life of Bio-Oil
Dry Skin Gel, specifically against the development of rancidity.

4.6.5. BHT

BHT stands for Butylated Hydroxytoluene and is a synthetic antioxidant. It is
commonly known by its INCI name, BHT.

BHT acts principally as a stabilising antioxidant for the plant extracts found in
Bio-Oil Dry Skin Gel. BHT acts synergistically with, and is more effective when
used in combination with, other antioxidants such as Tocopherol.

As an antioxidant, BHT has the effect of preserving the shelf-life of Bio-Oil Dry
Skin Gel, specifically against the development of rancidity.

4.6.6. Fragrance

Bio-Oil Dry Skin Gel is lightly fragranced with the same rose fragrance as
Bio-Oil Skincare Oil. The fragrance is a light, delicate rose. The INCI name for
the fragrance is Parfum. The fragrance comprises both natural and synthetic
ingredients.

The fragrance used in Bio-Oil Dry Skin Gel complies with the code of practice of
the International Fragrance Association (IFRA) and is thus considered to be safe
for topical use. The fragrance level in Bio-Oil Dry Skin Gel is 0.015%, which is
well below the limits set for its safe use. The fragrance is free of phthalates.

4.6.7. Allergens
There are four allergens in Bio-Oil Dry Skin Gel that are required to be listed.11 As
with most allergens, these are present in formulation plant oils and the fragrance.

The requirement to list allergens is not mandatory in all markets, however for
global consistency they are listed on all Bio-Oil products. The allergens present in
Bio-Oil Dry Skin Gel are as follows:

Citronellol
Farnesol
Limonene
Linalool

11. Certain allergens have been identified as the most common cause of skin reactions by the Scientific
Committee for Consumer Safety (SCCS), an independent risk assessment body, and these are listed
in Annex III of the EU Regulation (EC) No 1223/2009 on cosmetic products. The regulation requires
consumers be alerted to the presence of allergens in personal care products. They are required
to be listed in the ingredients should their inclusion in the final product exceed 0.001% in leave-on
products and 0.01% for rinse-off products.

19

Bio-Oil Dry Skin Gel has undergone derma testing and has been found to
be suitable for use on sensitive skin. In the unlikely event that a consumer
experiences an allergic reaction when using Bio-Oil Dry Skin Gel, it is probable
that the consumer has a sensitivity to one of the allergens present in the
fragrance and/or plant oils. Most allergic responses are likely to subside within
two to three days after use of the product has been discontinued.
4.6.8. Colourant
The colourant used in Bio-Oil Dry Skin Gel is a water-soluble cosmetic dye also
known as Red No 33. The INCI name is CI 17200.
Retention samples of Bio-Oil Dry Skin Gel show that the colour does not change
over time. A small change in colour, as a result of imperfect storage conditions, is
unlikely to affect its efficacy.

4.7. Safety assessment

Bio-Oil Dry Skin Gel has undergone a safety assessment by a qualified
toxicologist and has been classified as safe for its intended use by adults,
including pregnant and lactating women, and children over three years old.12

12. In accordance with Regulation (EC) No 1223/2009 of the European Parliament and of the Council
of 30 November 2009 on cosmetic products (recast). The intended use of the cosmetic product
and the anticipated system exposure to individual ingredients are taken into account in the safety
assessment; and an appropriate weight-of-evidence approach is used for reviewing data from all
existing sources.

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5. Testing

A number of clinical trials, derma tests, lab tests and user trials have been
conducted in order to support the efficacy of Bio-Oil Dry Skin Gel.13 The following
trials and tests have been conducted. Each is described in detail in the following
section.

- Moisture efficacy clinical trial (2018).

- Dry skin user trial (2017).

- Suitable for sensitive skin derma test (2017).

- Non-comedogenic derma test (2018).

- Occlusivity test (2018).

5.1. Moisture efficacy clinical trial

Trial centre
Thomas J. Stephens & Associates, Inc., Texas, United States of America, 2018.

Objective
To assess the moisturising efficacy of Bio-Oil Dry Skin Gel.

Sample
Subjects: 28 female participants (of whom 1 with Fitzpatrick14 skin type I, 13 with
skin type II and 14 with skin type III). Age of participants: 29 to 65.

Methodology
Split-body, evaluator-blinded, randomised, controlled clinical trial. A 1-week dry
down period was followed by a 2-week treatment period and a 3-day regression
period. During the 2-week treatment period subjects applied Bio-Oil Dry Skin
Gel to the assigned lower leg, the opposite leg remained untreated. Clinical
evaluations were conducted at baseline and days 2, 4, 7, 9, 11 and 14 and on
regression days 1, 2 and 3. Subjects were clinically graded for dryness (on a
scale from 0 – 5). Bioinstrumentation measurement of skin hydration was by
Corneometer and SKICON. Bioinstrumentation measurement of TEWL as an
indicator of barrier function, was by Tewameter.

13. Over the years cosmetic science has advanced and the beauty industry has evolved. As a result,
products are making stronger and more powerful claims about their efficacy. In order to protect
consumers, advertising authorities police such claims, ensuring that they can be substantiated in
accordance with internationally accepted codes of practice.

14. Internationally accepted scale from 1 – 6 which categorises the pigmentation of skin and the
associated characteristics.

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Result
Compared to the untreated side, Bio-Oil Dry Skin Gel showed statistically
significant improvements in clinical grading of dryness, SKICON measurements
and Corneometer measurements, at all time points; and in Tewameter
measurements, at treatment day 14 and regression day 3. For clinical grading
of dryness statistically significant improvements were evident in 82% of subjects
after only 2 days. After 2 weeks 100% of subjects showed a statistically
significant result, with the extent of the improvement almost triple that at day
2. Three days after treatment was stopped, 93% of subjects had maintained a
statistically significant improvement compared to the start of the study.

5.2. Dry skin user trial

Trial centre
Ayton Global Research, Somerset, United Kingdom, 2017.

Objective
To assess the performance of Bio-Oil Dry Skin Gel in the alleviation of dry skin on
the body, in a 102-person user trial.

Sample
Subjects: 102 female participants with self-assessed ‘Very Dry’ skin on the body.
Age of participants: 18 and over.

Methodology
A 2-week, single-placement, in-home user trial. Participants were instructed to
apply product daily to clean, dry skin. Two short questionnaires were completed:
the first after initial application and the second after 2 weeks of using the
product.

Result
Application
94% of participants agreed that ‘the product is easy to apply’ and 96% of
participants agreed that ‘a little goes a long way’.

Absorption
- 83% of participants agreed that ‘the product absorbs easily into the skin’.

Hydration
- 92% of participants agreed that ‘the product leaves skin feeling immediately

moisturised’.

- 80% of participants agreed ‘their skin felt moisturised throughout the day’.

- 86% of participants agreed that ‘their dry skin improved over the course of the
2-week period’.

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- 85% of participants agreed that ‘their skin looks better than it did at the
beginning of the 2-week period’.

Overall
- 62% of participants agreed that ‘the product is better than anything they have

used before for dry skin’.

5.3. Derma tests

5.3.1. Sensitive skin test

Trial centre
proDERM Institute for Applied Dermatological Research, Hamburg, Germany,
2017.

Objective
To assess the potential of Bio-Oil Dry Skin Gel to cause skin irritation.

Sample
Subjects: 31 participants (26 female and 5 male), thereof 52% with sensitive
skin according to self-estimation, 26% with type IV allergy (excepting cosmetic
ingredients) and 48% with atopy. Age of participants: 20 to 70.

Methodology
Randomised and controlled. Three areas were evaluated: area to which
demineralised water was applied (negative control), area to which Bio-Oil Dry
Skin Gel was applied, and area to which Sodium Dodecyl Sulfate (SDS) 1%
solution was applied (positive control – a known skin irritant). Test products were
applied once on the back for a period of 24 hours using an epicutaneous patch
test system. Visual evaluation to assess primary skin irritation was performed by
a trained grader 15 minutes after removal of the patches, and then 24 hours and
48 hours after patch removal. Skin reactions were rated on a scale from 0 – 4
(with 0 being no response and 4 being a very red and inflamed response).

Result
No subjects experienced any adverse reactions to the test product and scores
were the same as for the negative control, with a visual score of 0 (zero)
recorded for all subjects at all time points. The skin tolerability of Bio-Oil Dry Skin
Gel with respect to irritancy was therefore deemed to be ‘very good’.

5.3.2. Non-comedogenic study

Trial centre
proDERM Institute for Applied Dermatological Research, Hamburg, Germany,
2018.

23

Objective
To assess the potential of Bio-Oil Dry Skin Gel to form comedones (pimples).

Sample
Subjects: 24 participants with acne prone skin (17 female and 7 male). Age of
participants: 24 to 56.

Methodology
Randomised and controlled. The test product (under occlusion) and 2 negative
controls (untreated area (A) and untreated but occluded area (B)) were randomly
allocated to 3 test areas on the acne prone region of the upper back. Test
product was applied to the same test area 3 times per week over 4 weeks (12
applications in total). At the end of the study, 1 Skin Surface Biopsy (SSB) was
taken from each of the test areas, using the method of Marks and Dawber. The
presence of enlarged micro-comedones was evaluated in an evaluator-blinded
manner using the ranking scales of Mills and Kligman.

Result
Bio-Oil Dry Skin Gel was found to be non-comedogenic, performing significantly
better than both negative controls.

5.3.3. Occlusivity study

Trial centre
Rigano Laboratories, Milan, Italy, 2018.

Objective
To experimentally determine the occlusivity of Bio-Oil Dry Skin Gel and thereby its
ability to help the skin to retain moisture by reducing TEWL.

Methodology
Known quantities of water were placed in beakers covered with a semi-
permeable membrane called Vitro-Skin™, which mimics the surface properties
of human skin. Product was applied to the membrane and the rate of water loss
from the beakers was measured over time. This was compared with the rate of
water loss from control beakers, without any product on the membrane.

Result
The water vapour transmission rate (WVTR) test methodology is a standard
test for measuring the occlusivity of products. A reduction in the WVTR value
indicates that a particular formulation is occlusive. Bio-Oil Dry Skin Gel was
shown to reduce the WVTR values statistically compared to the untreated control
when applied to the Vitro-Skin™ membrane, indicating that Bio-Oil Dry Skin Gel
will help the skin to retain moisture.

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6. Manufacture

6.1. GMP certification

The global production of Bio-Oil Dry Skin Gel is centralised at the production
facility in Johannesburg, South Africa. The purpose-built and state of the art
facility conforms to the Good Manufacturing Practice (GMP) requirements of ISO
22716:2007 for cosmetic products.

6.2. Raw materials

All raw materials used in the manufacture of Bio-Oil Dry Skin Gel are
accompanied by a Certificate of Analysis (COA). The COA documents the tests
performed by the supplier to verify that the raw materials comply with pre-agreed
specifications. Samples are tested from each batch by independent quality
control (QC) analysts to obtain assurance over the integrity of the raw materials.
No raw materials are released from quarantine to the production line until the
tests have been passed.

6.3. Packaging materials

All packaging materials used in the manufacture of Bio-Oil Dry Skin Gel are
accompanied by a Certificate of Conformance (COC). The COC documents the
tests performed by the supplier to verify that the packaging materials comply
with pre-agreed specifications. Samples are measured and tested on delivery
by independent QC analysts to ensure conformance with specifications. No
packaging materials are released to the production line until tests have been
completed.

6.4. Mixing, filling and packing quality controls

Bio-Oil Dry Skin Gel ingredients are weighed and mixed by trained process
operators. A unique batch number is allocated at the time of mixing. A sample
from the finished batch is taken to the laboratory and tested for appearance,
odour, density and viscosity. A sample is also sent for microbiological analysis.
The sample is retained for five years.

The entire filling and packing facility is temperature and humidity controlled.
The air passes through a high efficiency particulate air (HEPA) filtering system
to prevent dust contamination. Employees working on the production line wear
hats, gloves, coats and shoe covers to maintain a high standard of hygiene and
to further reduce the possibility of contamination.

Samples of Bio-Oil Dry Skin Gel are taken off the line at regular intervals and are
inspected by the QC department as a precaution against extraordinary defect;

25

tubs, lids, labels, batch numbers, shrink wrap and shippers are all checked. A
retention sample from each batch is kept for five years. All testing equipment
used in the quality assurance process are regularly checked and calibrated to
ensure that they provide accurate data in use.

6.5. Batch numbers and retention samples

Bio-Oil Dry Skin Gel complies with the GMP requirement to print a batch number
on the bottle, carton and shipper. A sample of each packaging batch is retained
for five years. In the event of a consumer complaint, this allows traceability of the
product back to the original batch.

6.6. No harmful substances generated

No harmful emissions, hazardous waste or wastewater is generated in the
production of Bio-Oil Dry Skin Gel.

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7. Application

7.1. How to apply

When applying a traditional dry skin product, a large quantity needs to be used
as the majority of these products, being predominantly water, evaporate when
coming into contact with skin. Since Bio-Oil Dry Skin Gel is an oil, substantially
less product needs to be used to cover the same body area.
Apply a small amount to dry skin as required. In the case of persistent dry skin,
apply daily.
Bio-Oil Dry Skin Gel was specifically formulated as a dry skin treatment for the
body, however it may also be used on the face.

7.2. How long to use

Bio-Oil Dry Skin Gel is designed to both prevent and treat dry skin conditions.
The product may be used as frequently as needed and on an ongoing basis.

7.3. Use in conjunction with a skincare routine

For maximum absorption, Bio-Oil Dry Skin Gel should be applied to cleansed
skin after showering. If applying a moisturiser, sun protection lotion or other face
cream, only do so once Bio-Oil Dry Skin Gel has been completely absorbed into
the skin. For all over body use, apply Bio-Oil Dry Skin Gel after showering or
bathing.
Bio-Oil Dry Skin Gel’s results will vary from individual to individual.

7.4. Use on babies

The safety of using Bio-Oil Dry Skin Gel on children under the age of three has
not been specifically assessed.

7.5. Use during pregnancy and breastfeeding

The safety of using Bio-Oil Dry Skin Gel during pregnancy and breastfeeding has
not been specifically assessed.

27

7.6. Use in the sun

It is safe to use Bio-Oil Dry Skin Gel in the sun, however the product offers no
protection against the harmful effects of the sun’s UVA and UVB rays and it is
therefore important to use the product in conjunction with a broad-spectrum
sunscreen with an SPF of at least 30.
Bio-Oil Dry Skin Gel was not specifically formulated to use as an after sun
treatment. Sunburn is an inflammatory response in the skin that is best alleviated
by a product specifically targeted to treat sunburn and inflamed skin.

7.7. Use on or near mucosal membranes

Bio-Oil Dry Skin Gel contains a low level of fragrance and therefore is not
recommended to use on mucosal membranes.

7.8. Use with various skin types

7.8.1. Sensitive skin
Bio-Oil Dry Skin Gel can be used on sensitive skin. In a skin irritation study
conducted on 31 participants aged 20 to 70 with sensitive skin, no subjects
experienced any adverse reactions to Bio-Oil Dry Skin Gel.

7.8.2. Oily skin
Bio-Oil Dry Skin Gel can be used on oily skin. In a trial conducted on 24
participants aged 24 to 56 with acne-prone skin, Bio-Oil Dry Skin Gel was found
to be non-comedogenic.

7.9. Use with various skin conditions

7.9.1. Acne-prone skin
Bio-Oil Dry Skin Gel can be used on acne-prone skin. In a trial conducted on 24
participants aged 24 to 56 with acne-prone skin, Bio-Oil Dry Skin Gel was found
to be non-comedogenic. It is advisable for people suffering from acne to seek
the advice of a medical practitioner before using Bio-Oil Dry Skin Gel.

7.9.2. Psoriasis
Bio-Oil Dry Skin Gel can offer relief from the symptoms of psoriasis, such as
dryness, itching and flaking, but cannot offer a cure. It is advisable for people
suffering from psoriasis to seek the advice of a medical practitioner before using
Bio-Oil Dry Skin Gel.

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7.9.3. Eczema
Bio-Oil Dry Skin Gel can offer relief from the symptoms of eczema such as
dryness, itching and flaking, but cannot offer a cure. It is advisable for people
suffering from eczema to seek the advice of a medical practitioner before using
Bio-Oil Dry Skin Gel.

7.10. Accidental ingestion

In the event of the accidental ingestion of a large amount of Bio-Oil Dry Skin Gel,
it is unlikely that any adverse effects – other than possible feelings of nausea
and diarrhoea – would be experienced because Bio-Oil Dry Skin Gel is not toxic.
However, it is recommend that you seek the advice of a medical practitioner if
Bio-Oil Dry Skin Gel is ingested, especially by an infant or child.

7.11. Removing from clothing

Bio-Oil Dry Skin Gel can be easily removed from most clothing and fabrics by
washing the item in a warm wash cycle or by dry cleaning. It is recommended
the care instructions given inside the garment are followed.

29

8. Adverse reactions

8.1. Causes of adverse reactions

While Bio-Oil Dry Skin Gel has a safe toxicological profile and meets international
regulations in this respect, as with all cosmetic products, there exists a risk that
Bio-Oil Dry Skin Gel users may encounter an adverse reaction when using the
product.
In the rare case of an adverse reaction to Bio-Oil Dry Skin Gel it is most likely to
have been caused by one of the following factors.

8.1.1. Allergens
Regulations require that consumers be alerted to the presence of allergens in
personal care products.15 Bio-Oil Dry Skin Gel contains four of these allergens,
which are naturally present in the plant oils, and also in the fragrance.

8.1.2. Hormonal changes
Changes in the skin’s condition are influenced by the hormonal activity in our
bodies. For this reason, people frequently experience changes in their skin
condition during puberty, pregnancy and menopause, when there are significant
hormonal changes taking place. Hormonal changes can cause the skin to react
unpredictably to certain products.

8.2. Typical symptoms of an adverse reaction

Symptoms of an adverse skin reaction can include rashes, swelling and
inflammation, which would typically occur in the area to which the product
was applied. These reactions may be accompanied by itchiness and slight
discomfort. In most cases, adverse reactions will subside within two to three
days after use of the product has been discontinued. Until it has returned to its
original condition, the skin may appear dry and flaky as the reaction subsides.

8.3. What to do in the event of an adverse reaction

If someone experiences an adverse reaction to Bio-Oil Dry Skin Gel, use of the
product should be discontinued immediately. In most cases, the reaction should
subside within two to three days.

15. Certain allergens have been identified as the most common cause of skin reactions. Many cosmetic
products make use of plant oils and fragrances, which may contain potential allergens.

30

8.4. Conducting a simple allergy test

If there is any concern regarding a potential allergic response to the application
of Bio-Oil Dry Skin Gel, it is wise to carry out a simple allergy test to check this.
This is done by applying a small amount of Bio-Oil Dry Skin Gel to the inner
forearm and waiting for a period of 24 hours to see if any reaction occurs.
A perceptible reddening of the skin (erythema) or slight swelling of the skin
(oedema) may indicate the potential for an allergic response.

8.5. Record of adverse reactions

Details of all adverse reactions are recorded and monitored on a statistical basis.

31

9. Packaging

9.1. Description

Each unit of Bio-Oil Dry Skin Gel is made with custom-designed and tamper-
proof components. These include a tub with a label and flip top cap with seal.
Each tub label is printed with country specific artwork and language translation.
Tubs are packed individually or shrunk in packs of three or six. A label printed
with a country specific barcode is placed on the shrink pack. Shrink packs or
individual units are placed in a shipper with a shipper label. Shippers are placed
on a wooden pallet.

9.2. Brand name

In order to comply with country-specific regulations and to provide a name which
resonates with consumers, the Bio-Oil brand name has been adapted in certain
markets. These include Japan, where it is called Bioil, and certain European
markets, where it is called Bi-Oil.

9.3. Pack sizes

Bio-Oil Dry Skin Gel is available in three pack sizes.

50ml 100ml 200ml

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9.4. Materials

Bio-Oil Dry Skin Gel primary and secondary packaging materials are detailed
below. All materials are recyclable.

Item Material Recyclable
Lid Yes
High density
Tub polyethylene/
linear low density
polyethylene blend
(HDPE/LLDPE)

Polypropylene (PP) Yes

Tub label Polypropylene (PP) Yes

Shrink Low density Yes
polyethylene
(LDPE)

Shrink label Semi-gloss decal Yes

Shipper Corrugated board Yes

Shipper label In-line printing Yes

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9.5. Packaging symbols

Various packaging symbols and other information is used on the Bio-Oil Dry Skin
Gel packaging. These are detailed below.

Symbol Name Description
Recyclable
The recycling symbol is called a mobius and signifies
Date of minimum that the packaging can be recycled.
durability / expiry
date Use in Bio-Oil Dry Skin Gel:

Period after All Bio-Oil Dry Skin Gel packaging materials are
Opening (POA) recyclable.

The date of minimum durability is the date until
which a cosmetic product, stored under appropriate
conditions, will continue to fulfil its initial function.
It should be used on products with a minimum
durability of 30 months or less. The date itself is
preceded by the symbol or the words ‘Best used
before the end of’.16

Use in Bio-Oil Dry Skin Gel:

No date of minimum durability is required for Bio-Oil
Dry Skin Gel.17

The Period after Opening (PAO) symbol is required to
be shown on cosmetic products that have a minimum
durability of more than 30 months. The PAO symbol
shows the period of time after opening (expressed in
months (M)) for which a product is safe and can be
used without any harm to the consumer.18

Use in Bio-Oil Dry Skin Gel:

Bio-Oil Dry Skin Gel has a PAO of 12 months.19

16. EU Regulation (EC) No 1223/2009.
17. Tests have found that Bio-Oil Dry Skin Gel shows no sign of deterioration after 30 months. As a

result, no best before date is required, however regulatory authorities in some countries still insist on
one, in which case this is added to the country specific packaging
18. EU Regulation (EC) No 1223/2009.
19. In markets where a best before date (or expiry date) is required to be listed on the pack, the PAO
may not be required at all; and in others, where regulations define a specific calculation for the PAO,
the period of time may differ.

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Symbol Name Description
Filling volume
estimate verified The ‘e’ symbol stands for the estimated filled volume
of the product expressed in ml and/or fl.oz. The
Halaal symbol may only be used if the filled amounts are
certification audited by an internationally recognised standards
institution.
Kosher
certification Use in Bio-Oil Dry Skin Gel:

Bio-Oil Dry Skin Gel tubs are consistently filled to
an accepted international standard. The National
Regulator for Compulsory Specifications (NRCS)
audits the filling lines annually to ensure that the
actual content of product in the Bio-Oil Dry Skin
Gel tubs is as indicated on the packaging. The ‘e’
(estimated) symbol may therefore be used on Bio-Oil
Dry Skin Gel packaging.

A Halaal authority symbol signifies that the product
is Halaal and has been certified by an international
Halaal authority.

Use in Bio-Oil Dry Skin Gel:

Bio-Oil Dry Skin Gel is Halaal certified by the South
African National Halaal Authority (SANHA).20

A Kosher authority symbol signifies that the product
is Kosher and has been certified by an international
Kosher authority.

Use in Bio-Oil Dry Skin Gel:

Bio-Oil Dry Skin Gel is Kosher certified under the
supervision of the Cape Beth Din, Cape Town, South
Africa.21

20. SANHA is an international, non-profit organisation, representing the Muslim Ummah community
on all matters pertaining to the general application of the term Halaal with specific reference to
Islamic dietary laws. SANHA is among the founder members of the World Halaal Council and enjoys
international recognition from Muslim countries as well as the broader global community. SANHA’s
membership comprises of leading theological bodies and leading professional organisations of
global repute.

21. The Beth Din is the Ecclesiastical Court of the Union of Orthodox Synagogues of South Africa (UOS).
The UOS is an incorporated, not-for-gain association representing the Jewish community on all
matters pertaining to the general application of the term Kosher.

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10. Other information

10.1. Not tested on animals

Bio-Oil Dry Skin Gel and its constituent raw materials are manufactured in
compliance with EU regulations pertaining to animal testing for cosmetic
purposes.22 Neither Bio-Oil Dry Skin Gel, nor any of its ingredients, are tested on
animals by either Bio-Oil or any of its raw material suppliers.

10.2. Veganism

Bio-Oil Dry Skin Gel contains lanolin, which is a wax extracted from sheep’s
wool. As such, Bio-Oil Dry Skin Gel is not vegan.

10.3. Use of natural ingredients

Bio-Oil Dry Skin Gel is not a completely natural product. While it does contain
a number of natural ingredients such as chamomile, lavender, rosemary and
calendula extract, it also contains ingredients that are not classified as natural.

10.4. Soy allergens

While soy proteins are a common allergen, soybean oil – used as a carrier for
calendula oil – is not considered to be an allergen by the European Food Safety
Authority (EFSA). However, it is thought that soybean oil may contain traces of
soy proteins. It is therefore possible that Bio-Oil Dry Skin Gel is not completely
free from soy allergens.

10.5. Palm oil

Palm oil or palm kernel oil is not directly used as an ingredient in Bio-Oil Dry
Skin Gel. This is why it doesn’t appear anywhere on the INCI declaration.
However, some of the ingredients included in the formulation are derived from
palm or palm kernel oil. Bio-Oil endeavours to source all such raw materials from
suppliers who are active members of the Roundtable on Sustainable Palm Oil
(RSPO)23.

22. This is in accordance with Regulation (EC) No 1223/2009 of the European Parliament and of the
Council of 30 November 2009 on cosmetic products (recast). The regulation placed a ban on animal
testing on ingredients used in cosmetic products from 11 March 2013, known as the fixed cut-off
date. All raw materials used in Bio-Oil Dry Skin Gel comply with this regulation.

23. The RSPO is an international non-profit organisation formed in 2004 with the objective of promoting
the growth and use of sustainable oil palm products through credible global standards and
engagement of stakeholders.

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10.6. Extreme temperatures

Bio-Oil Dry Skin Gel should ideally be stored between15 and 25 degrees Celsius.
At extreme high or low temperatures, it is possible that the product consistency
may change. This will not affect the efficacy of the product.

10.7. REACH registration

Bio-Oil Dry Skin Gel’s raw materials suppliers are all fully compliant with the
requirements of the REACH directive.24

10.8. Nanotechnology

Bio-Oil Dry Skin Gel contains no ingredients that utilise nanotechnology or any
other ultrafine particle delivery system.

10.9. Does not contain

10.9.1. Preservatives
Bio-Oil Dry Skin Gel does not contain any ingredients classified as a
preservative.25 Bio-Oil Dry Skin Gel does however contain Tocopherol and BHT.
These function as antioxidants and are included in the formulation to protect the
natural oils.

10.9.2. Parabens
Bio-Oil Dry Skin Gel does not contain parabens. Parabens are commonly used
preservatives in topical pharmaceutical preparations and cosmetics. They are
controversial due to their possible link to breast cancer and other oestrogenic
effects, although to date this concern is unproven.

10.9.3. Phthalates
Bio-Oil Dry Skin Gel does not contain phthalates. Phthalates are organic
chemicals produced from oil and are the most common plasticisers in the world.
They are also often used in synthetic fragrances as solvents, and are contentious
as they may pose various health risks to the body.

24. REACH (Registration, Evaluation and Authorisation of Chemicals) is a European directive (Regulation
(EC) No. 1997/2006) that aims to improve protection of human health and the environment from the
risks of chemicals and aims to maintain the competitiveness of EU industry. REACH requires that
suppliers register with the European Chemical Agency those raw materials whose annual sales (in
Europe) exceed certain specified amounts.

25. Annex V of EU Regulation (EC) No 1223/2009 lists ingredients which are classified as preservatives.

37

10.9.4. Food allergens
Bio-Oil Dry Skin Gel does not contain the following list of food allergens:
dairy products, eggs, tree nuts, peanuts, sesame seeds, mustard, lupin, fish,
crustaceans, molluscs, gluten, alcohol, celery, iodine or iodine-containing
ingredients, sulphur dioxide and sulphites.

38

11. Glossary of terms

Adverse reaction The negative effect experienced by a user that may have been
Allergen caused by the use of a topically applied product.
Alpha hydroxy acid
Anhydrous Any substance included in a cosmetic product that may induce
Antimycotic an allergy.
Antioxidant
Astringency Naturally occurring organic acids that function as humectants
Bioavailable and exhibit exfoliation properties.
Ceramides
Collagen Without the presence of water.

Comedogenic Antifungal, inhibits the growth of fungi.
Comedones
A substance that inhibits oxidisation, thereby preventing or
Corneocytes slowing damage to cells caused by free radicals.
Cytotoxic
Dermis The causing of skin cells to contract, resulting for example in
Desquamation minimised pores.
Eczema
The mechanism by which an ingredient is functionally active in
the skin.

A family of waxy lipid molecules composed of sphingosine and a
fatty acid, found in skin lipid bilayer.

The main structural protein in the human body that holds
the body together, providing strength and structure. Occurs
throughout the body but is especially prevalent in the skin, bones
and connective tissue.

Causing blocked pores and blackheads.

Plural of comedo. Small bumps found on the skin. Can be an
open blackhead due to surface pigment; or a closed whitehead
due to a blocked follicle.

Polygonal cells found in the upper layers of the skin which
interlock with one another to form the stratum corneum.

Toxic to living cells.

The thick layer of connective tissue located between the
epidermis and the subcutaneous tissues of the body.

The natural loss of dead skin cells from the surface of the stratum
corneum.

A condition that causes skin to become red, itchy, inflamed,
sometimes blistering and weeping.

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Elastin The highly elastic protein in connective tissue that allows tissues
Emulsifier in the body to resume their shape after stretching or contracting.

Emulsion Additives that help two otherwise incompatible phases to
be dispersed into one another. One end likes to be in an oily
Epidermis environment, and the other in a water environment.
Erythema
Ester Two-phase formulation system, comprising oil and water, in which
one of the phases is dispersed in the other in the form of very fine
Esterification droplets.
Free radicals
Glycerides The outermost layer of the skin which provides a barrier to the
Glycol internal body.
Humectants
Reddening of the skin, caused by increased blood flow.
Hydrophobic
Hydrophilic A material produced by the reaction between an acid and an
Keratolytic alcohol. In skincare, esters are frequently used to enhance the
Lipid appearance and feel of product on the skin.

Lipid bilayer The chemical process by which oils are converted to esters,
usually in the presence of a solvent.
Lipophilic
Microorganisms Unstable atoms that react quickly with other substances to cause
oxidative stress, resulting in the breakdown of body cells.

Esters formed from glycerine and fatty acids.

One of any number of ingredients that contain hydroxyl groups,
which typically have hydrophilic properties.

Materials that when applied to the skin, attract moisture from
surrounding environment back into the skin, thereby increasing its
moisture content.

Water-hating.

Water-loving.

The softening and shedding effect of the outer layer of the skin.

Another word for ‘fat’. Chemically defined as a substance that
does not dissolve in water. Lipids are the main constituents of
plant and animal cells together with carbohydrates and proteins.

A thin polar membrane consisting of two layers of lipid molecules.
Found in the epidermis and is primarily responsible for the lipid
barrier function of the skin.

Oil-loving.

An organism that is so small that it is microscopic (invisible to the
eye). Also referred to as a microbe.

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