DSG book

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. Introduction 1
2. Understanding dry skin 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 2
2.4.1. External factors 2 2.4.2. Internal factors 3
2.5. Dry skin treatments 3
2.5.1. How occlusion works 3
2.5.2. How humectancy works 3
3. Research and development 4
3.1. Observation 4 3.2. Current dry skin products 4 3.3. Criticism of current dry skin products 4 3.4. Opportunity for a new dry skin product 4 3.5. Gel - a new way to treat dry skin 5 3.6. Emulsions vs Bio-Oil Dry Skin Gel 5
4. Formulation 6
4.1. Ingredient declaration 6 4.2. Ingredients explained 7
4.3.2. Isopropyl Palmitate 10
4.3.3. Triisononanoin 10 4.3.4. PurCellin OilTM 10 4.3.5. Caprylic/Capric Triglyceride 10 4.3.6. Isostearyl Isostearate 11
4.3. Occlusive phase ingredients 9
4.3.1. Mineral oil 9


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
4.4.5. Sodium Lactate 13 4.4.6. Sodium PCA 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
4.7. 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
4.4.3. Hyaluronic acid 13
4.4.4. Lactic acid 13
4.4.7. Butylene Glycol 13
4.4.8. Gluconolactone 13
4.6.7. Allergens 19
4.6.8. Colourant 20


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
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.
The skin produces natural moisturising factor (NMF)1
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 considered the superior option.
2.5.1. How occlusion works
two beakers of water and add oil to one of the beakers. The oil will rise to the top
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.
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
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
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.
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
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
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
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
moisturising effect. Humectants are mixed into the water part of an emulsion as
they do not dissolve in oil.


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 and waxes
10% humectants 70% water
87% oils, butters and waxes
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
Hyaluronate, Octyldodecyl PCA, Sucrose Laurate, Sucrose Stearate, Lactic
Bisabolol, Helianthus Annuus Seed Oil, Silica, Glycine Soja Oil, BHT, Retinyl Palmitate, Tocopheryl Acetate, Niacinamide, Linoleic Acid, Linolenic Acid,
Rosmarinus Officinalis Leaf Oil, Lavandula Angustifolia Oil, Parfum, Citronellol, Farnesol, Limonene, Linalool, CI 17200.
Myristate, Urea, Caprylic/Capric Triglyceride, Isostearyl Isostearate, C26-28
Alkyl Dimethicone, Sodium Lactate, Gluconolactone, Sodium PCA, Sodium
Acid, Lanolin, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer,
Tocopherol, Anthemis Nobilis Flower Oil, Calendula Officinalis Extract,
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
in a product formulation must be listed. Those ingredients whose inclusion is greater than 1% of the than 1% can be listed in any order. The exact quantity of each ingredient is kept confidential.
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
formulation should be listed from highest to lowest percentage. Ingredients whose inclusion is less
6
3.


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 category
Occlusive phase
ingredients
Ingredient
Mineral oil
Isopropyl Palmitate Triisononanoin PurCellin OilTM
Isostearyl Isostearate
Isopropyl Myristate
Shea butter
Lanolin
C26-28 Alkyl
Dimethicone
Urea
Glycerin Hyaluronic acid
Lactic acid Sodium Lactate Sodium PCA Butylene Glycol Gluconolactone
INCI name (European)
Paraffinum Liquidum
Isopropyl Palmitate
Triisononanoin
Cetearyl
Ethylhexanoate Isopropyl Myristate
Isostearyl Isostearate
Isopropyl Myristate
Butyrospermum Parkii Butter
Lanolin
C26-28 Alkyl
Dimethicone
Urea
Glycerin
Sodium
Hyaluronate
Lactic Acid Sodium Lactate Sodium PCA Butylene Glycol Gluconolactone
INCI name (US)
Paraffinum Liquidum (Mineral Oil)
Isopropyl Palmitate
Triisononanoin
Cetearyl
Ethylhexanoate Isopropyl Myristate
Isostearyl Isostearate
Isopropyl Myristate
Butyrospermum Parkii (Shea) Butter
Lanolin
C26-28 Alkyl
Dimethicone
Urea
Glycerin
Sodium
Hyaluronate
Lactic Acid Sodium Lactate Sodium PCA Butylene Glycol Gluconolactone
Caprylic/Capric
Triglyceride
Caprylic/Capric
Triglyceride
Caprylic/Capric
Triglyceride
Humectant phase ingredients
7


Ingredient category
Barrier repair and maintenance
Ingredient
Vitamin A
Vitamin B3 Vitamin E Vitamin F
Rosemary oil Lavender oil
Chamomile oil Calendula extract
Pseudo-Ceramide Bisabolol
Dimethicone/ Vinyl Dimethicone
INCI name (European)
Retinyl Palmitate
Helianthus Annuus Seed Oil
Niacinamide
Tocopheryl Acetate
Linoleic Acid
Linolenic Acid
Rosmarinus Officinalis Leaf Oil
Lavandula
Angustifolia Oil
Anthemis Nobilis Flower Oil
Extract
Glycine Soja Oil
Octyldodecyl PCA Bisabolol
Dimethicone/ Vinyl Dimethicone
INCI name (US)
Retinyl Palmitate
Helianthus Annuus (Sunflower) Seed Oil
Niacinamide Tocopheryl Acetate Linoleic Acid Linolenic Acid
Rosmarinus
Officinalis
(Rosemary) Leaf Oil
Lavandula Angustifolia (Lavender) Oil
Anthemis Nobilis Flower Oil
Extract
Glycine Soja
(Soybean) Oil
Octyldodecyl PCA
Bisabolol
Dimethicone/ Vinyl Dimethicone
8
Crosspolymer
Calendula Officinalis
Crosspolymer
Calendula Officinalis
Crosspolymer


Ingredient category
Other ingredients
Ingredient
Silica
Water
Sucrose Laurate Sucrose Stearate Tocopherol
BHT
Fragrance Allergens
INCI name (European)
Silica
Aqua
Sucrose Laurate Sucrose Stearate Tocopherol
BHT
Parfum Citronellol Farnesol Limonene Linalool
INCI name (US)
Silica
Water/Aqua/Eau Sucrose Laurate Sucrose Stearate Tocopherol
BHT
Fragrance (Parfum) Citronellol
Farnesol
Limonene
Linalool
Red 33 (CI 17200)
Colourant
CI 17200
4.3. Occlusive phase ingredients
The use of occlusive ingredients is the gold standard in the treatment of dry
corneum thereby preventing unwanted water loss. This is the most effective way to treat dry skin.
4.3.1. Mineral oil
Pharmaceutical grade mineral oil
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
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
4 – 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
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 Triisononanoin is a
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 OilTM is a mixture of two ingredients, both of which are esters. Their INCI names are Cetearyl Ethylhexanoate and Isopropyl Myristate.
PurCellin OilTM 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 OilTM 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
to deliver a lightly-textured, clear, odourless and non-
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.
medical fraternity. 10
– materials that absorb rapidly into the skin’s surface.
transparent, water-like liquid.
PurCellin OilTM
Caprylic/Capric Triglyceride is a natural derivative of coconut oil which is
combined with glycerine5
greasy oil.
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


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 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
Myristate helps makes Bio-Oil Dry Skin Gel feel non-greasy and light.
4.3.8. Shea butter
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
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.
skin. Isostearyl Isostearate has skin conditioning and moisturising properties
through the forming of a film on the skin. Clinical studies show that Isostearyl
making the formulation ‘skin-friendly’. Isopropyl Myristate is easily absorbed into
the skin, ensuring the rapid penetration of the formulation ingredients. Isopropyl
Shea butter is a semi-solid, light yellowish fat derived from the leaves of the
African Shea tree.
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.
11


4.3.10. C26-28 Alkyl Dimethicone
C26-28 Alkyl Dimethicone is a synthetic silicone resin, which appears as a
cream-coloured waxy substance.
4.4. Humectant ingredients
After occlusive ingredients, humectant ingredients – generally called humectants 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, 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
of silicone dispersed in the external water phase, the formulation has a light and non-greasy feel both on application and post absorption.
Urea is approximately 7% of NMF.
medical fraternity. 12
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.
– 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
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
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
6.
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


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,
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.
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
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.
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
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
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
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
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
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


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
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.
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
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 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.
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
0.05% Rosemary oil and is therefore safe to use topically. 16
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
9.
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


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 Glycine Soja Oil.
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 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.
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
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
Pseudo-Ceramide
17


4.5.11.
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. powdery texture when applying the gel.
4.6.2. Water
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
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. 18
Dimethicone/vinyl Dimethicone Crosspolymer
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
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
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


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.
well below the limits set for its safe use. The fragrance is free of phthalates.
4.6.7. Allergens
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.
in Annex III of the EU Regulation (EC) No 1223/2009 on cosmetic products. The regulation requires
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
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.
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
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
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
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
12.
existing sources. 20
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


5. Testing
A number of clinical trials, derma tests, lab tests and user trials have been
The following
- 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
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
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
indicator of barrier function, was by Tewameter.
13.
products are making stronger and more powerful claims about their efficacy. In order to protect
14. Internationally accepted scale from 1 – 6 which categorises the pigmentation of skin and the associated characteristics.
conducted in order to support the efficacy of Bio-Oil Dry Skin Gel.13
trials and tests have been conducted. Each is described in detail in the following
section.
Subjects: 28 female participants (of whom 1 with Fitzpatrick
14
Gel to the assigned lower leg, the opposite leg remained untreated. Clinical
scale from 0 – 5). Bioinstrumentation measurement of skin hydration was by
Corneometer and SKICON. Bioinstrumentation measurement of TEWL as an
Over the years cosmetic science has advanced and the beauty industry has evolved. As a result,
consumers, advertising authorities police such claims, ensuring that they can be substantiated in
accordance with internationally accepted codes of practice.
21


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
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’.
of dryness statistically significant improvements were evident in 82% of subjects
after only 2 days. After 2 weeks 100% of subjects showed a statistically
22


- 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
ingredients) and 48% with atopy. Age of participants: 20 to 70.
Methodology
Randomised and controlled. Three areas were evaluated: area to which
(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.
Subjects: 31 participants (26 female and 5 male), thereof 52% with sensitive
skin according to self-estimation, 26% with type IV allergy (excepting cosmetic
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
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
product was applied to the same test area 3 times per week over 4 weeks (12
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-SkinTM, 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-SkinTM membrane, indicating that Bio-Oil Dry Skin Gel will help the skin to retain moisture.
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
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
24


6. Manufacture 6.1. GMP certification
22716:2007 for cosmetic products.
6.2. Raw materials
performed by the supplier to verify that the raw materials comply with pre-agreed
No raw materials are released from quarantine to the production line until the tests have been passed.
6.3. Packaging materials
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
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
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
specifications. Samples are tested from each batch by independent quality
control (QC) analysts to obtain assurance over the integrity of the raw 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


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
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.
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
26


7. Application 7.1. How to apply
When applying a traditional dry skin product, a large quantity needs to be used
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
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.
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
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
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
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.
28
therefore important to use the product in conjunction with a broad-spectrum
sunscreen with an SPF of at least 30.


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
(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.
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
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
32


9.4. Materials
Bio-Oil Dry Skin Gel primary and secondary packaging materials are detailed below. All materials are recyclable.
Item Lid
Tub
Tub label
Shrink
Shrink label
Shipper
Shipper label
Material
High density polyethylene/ linear low density polyethylene blend (HDPE/LLDPE)
Polypropylene (PP)
Polypropylene (PP)
Low density polyethylene (LDPE)
Semi-gloss decal
Corrugated board
In-line printing
Recyclable Yes
Yes
Yes
Yes
Yes
Yes
Yes
33


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 that the packaging can be recycled.
Use in Bio-Oil Dry Skin Gel:
All Bio-Oil Dry Skin Gel packaging materials are recyclable.
Date of minimum durability / expiry date
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
Period after Opening (POA)
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.
34


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 symbol may only be used if the filled amounts are audited by an internationally recognised standards institution.
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.
Halaal certification
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
Kosher certification
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 purposes.
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
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
(RSPO) .
date. All raw materials used in Bio-Oil Dry Skin Gel comply with this regulation.
engagement of stakeholders. 36
compliance with EU regulations pertaining to animal testing for cosmetic 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.
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
suppliers who are active members of the Roundtable on Sustainable Palm Oil 23
22.
23.
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
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


10.6. Extreme temperatures
Bio-Oil Dry Skin Gel should ideally be stored between15 and 25 degrees Celsius.
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.
(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
Europe) exceed certain specified amounts.
Annex V of EU Regulation (EC) No 1223/2009 lists ingredients which are classified as preservatives.
At extreme high or low temperatures, it is possible that the product consistency
may change. This will not affect the efficacy of the product.
24.
25.
REACH (Registration, Evaluation and Authorisation of Chemicals) is a European directive (Regulation
suppliers register with the European Chemical Agency those raw materials whose annual sales (in
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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.
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11. Glossary of terms
Adverse reaction Allergen
Alpha hydroxy acid
Anhydrous Antimycotic Antioxidant
Astringency Bioavailable Ceramides Collagen
Comedogenic Comedones
Corneocytes Cytotoxic
Dermis Desquamation Eczema
The negative effect experienced by a user that may have been caused by the use of a topically applied product.
Any substance included in a cosmetic product that may induce an allergy.
Naturally occurring organic acids that function as humectants
and exhibit exfoliation properties.
Without the presence of water. Antifungal, inhibits the growth of fungi.
A substance that inhibits oxidisation, thereby preventing or slowing damage to cells caused by free radicals.
The causing of skin cells to contract, resulting for example in minimised pores.
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
Emulsifier
Emulsion
Epidermis
Erythema
Ester
Esterification
Free radicals
Glycerides
Glycol
Humectants
Hydrophobic
Hydrophilic
Keratolytic
Lipid
Lipid bilayer
Lipophilic
Microorganisms
The highly elastic protein in connective tissue that allows tissues in the body to resume their shape after stretching or contracting.
Additives that help two otherwise incompatible phases to be dispersed into one another. One end likes to be in an oily environment, and the other in a water environment.
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
droplets.
The outermost layer of the skin which provides a barrier to the internal body.
Reddening of the skin, caused by increased blood flow.
A material produced by the reaction between an acid and an alcohol. In skincare, esters are frequently used to enhance the appearance and feel of product on the skin.
The chemical process by which oils are converted to esters, usually in the presence of a solvent.
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.
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.
Another word for ‘fat’. Chemically defined as a substance that
does not dissolve in water. Lipids are the main constituents of
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