SKIN COSMETICS AND

ITS REGULATORY
ASPECTS

STUTI GUPTA SUBMITTED TO

75/MIP/SPS./23 DR. SUSHAMA TALEGAONKAR
DEPT. OF PHARMACEUTICS ASSOCIATE PROFESSOR
Table of contents
01 02 03

INTRODUCTION SKIN ANATOMY CLASSIFICATION

04 05 06 07

SKIN POWDERS CREAMS SUNSCREEN REFERENCE

SKIN
COSMETICS
• A cosmetic product can be defined as any substance or mixture of
substances intended to be applied to the external surfaces of the human
body (epidermis, hair, nails, lips, external genital organs), or to the teeth
and mucous membranes of the mouth, for the purpose of cleaning,
perfuming, or protecting them, modifying their appearance, keeping them in
good condition or correcting odours emanating from them.

• The products that are used on the epidermis are specifically denominated as
skincare products.
• A cosmetic product is made up of an active ingredient and other
substances (ingredients) that form the “base”, “vehicle” or presentation
of the product, including products called creams, lotions and gels.

• The vehicle is formulated to-

1) make the product suitable for efficiently transporting the active
ingredient to the target site, and
2) ensure that the active ingredient remains in the site of action within
the period of time necessary to achieve the desired effect.
SKIN ANATOMY
• Skin is the largest organ in the body and covers the
body's entire external surface. It is made up of three
layers, the epidermis, dermis, and the hypodermis, all
three of which vary significantly in their anatomy and
function.

• The skin's structure is made up of an intricate network

which serves as the body’s initial barrier against
pathogens, UV light, and chemicals, and mechanical
injury.

• It also regulates temperature and the amount of water

released into the environment.
Layers of Epidermis
Stratum basale, also known as stratum germinativum, is the
deepest layer, separated from the dermis by the basement
membrane (basal lamina).
The cells found in this layer are cuboidal to columnar
mitotically active stem cells that are constantly producing
keratinocytes. This layer also contains melanocytes.

Stratum spinosum, 8-10 cell layers, also known as the

prickle cell layer contains irregular, polyhedral cells
sometimes called “spines”. Dendritic cells can be found in
this layer.
Stratum granulosum, 3-5 cell layers, contains diamond
shaped cells with keratohyalin granules and lamellar
granules. Keratohyalin granules contain keratin precursors
and lamellar granules contain the glycolipids.

Stratum lucidum, 2-3 cell layers, present in thicker skin

found in the palms and soles, is a thin clear layer.

Stratum corneum, 20-30 cell layers, is the uppermost layer,

made up of keratin and horny scales made up of dead
keratinocytes, known as anucleate squamous cells. This is
the layer which varies most in thickness, especially in
callused skin. Within this layer, the dead keratinocytes
secrete defensins which are part of our first immune defense.
DERMIS HYPODERMIS

The dermis is connected to the epidermis The hypodermis is deep to the dermis and is
at the level of the basement membrane also called subcutaneous fascia. It is the
and consists of two layers, of connective deepest layer of skin and contains adipose
tissue, lobules along with some skin appendages like
the hair follicles, sensory neurons, and blood
The papillary layer is the upper layer, vessels.
thinner, composed of loose connective
tissue and contacts epidermis.
The reticular layer is the deeper layer,
thicker, less cellular, and consists of
dense connective tissue/ bundles of
collagen fibers.

The dermis houses the sweat glands,

hair, hair follicles, muscles, sensory
neurons, and blood vessels.
Cosmetics used on the epidermis are specifically denominated skincare products.

Skincare products can be presented in different physical states:

Solid (powders)
Face powder, Body powder, Compact powder, Rouges, Eyeshadows.

Liquid (solutions or suspensions)

Toners, Micellar water, Serums, Sunscreen.

Semisolid (gels or emulsions)

Sunscreen gels, Gel based creams, Cold cream, Vanishing Cream, Foundation cream,
Hand cream, Body lotion, Sunscreen lotion,
Skin Powders
Skin powders shall be classified into two types as follows:

a) Body powders shall incIude talcum powders, toilet powders, deodorant powders and dusting
powders. These shall consist principalIy of a finely-powdered free flowing absorbent innocuous
material such as natural talc (hydrous silicate of magnesium with the formula Mg 3Si4O10H2O) and may
contain small amounts of perfume and colouring matter, as well as other ingredients consistent with
the accepted practice in the cosmetic industry. The latter may include materials having anti-per spirant
and deodorant properties.

b) Face powders shall essentially be similar to body powder except that it shall be of finer particle
size and free from grit.
FACE POWDERS

Face powder is a cosmetic item that may be used to give the skin a specific touch, manage shine and
oil, or both, as well as give the skin a matte finishing look.
This matte texture, when paired with the powder's high transparency, may provide a unique soft effect
on the face, minimising the visibility of discolouration and softening the appearance of wrinkles and
lines to improve skin look. Powder evens out skin tone and tones the face.

They should have adherence, lightness, and transparency as their primary qualities

They should also tend to increase the natural elasticity and regular functions of the skin.
Formulation Of Face Powder
sr. Ingredients Uses
no
.
1. Talc Base

2. Zinc oxide Colourant & protection

3. Zinc Anti-caking agent

stearate
4. Kaolin Absorbent

5. Titanium Colouring agent

dioxide
6. Methyl Preservative
paraben
Dusting Powders
Dusting powder are meant for the external application to the skin and are generally applied in a very
fine state of subdivison to avoid local irritation.
Hence, dusting powders should be passed through seive no. 80 to enhance their
effectiveness.
Dusting powders are of 2 types:
• Medical
• Surgical
Dusting Powders
Medical dusting powders are used for superficial skin conditions, whereas surgical dusting
powder are used in body cavities and also on major wounds as a result of burns and umbilical cords of
infants.

Medical & Surgical dusting powders before use must be sterilized by dry heat method at 1600°C for 2
hrs.

In the preparation of dusting powder the talc or kaolin, starch are used commonly because these
are chemically inert.

They’re used as antifungal, antiseptic, antiperspirant, astringent, absorbent.

Requirements
• Ingredients — Unless specified otherwise, all the raw materials used in the manufacture of skin
powders shall conform to the requirements prescribed in the relevant Indian Standards where these
exist. Other ingredients shall comply with the provisions of IS 4707 (Part 2).

• The dyes, colours (pigments, lakes etc.) if used shall comply with the latest version of IS 4707
(Part 1) subject to the provision of schedule Q of Drugs and Cosmetic Act. These shall be not more
than sparingly soluble either in water or in oil

• The product shall not be manufactured from any carcinogenic ingredients.

• Product shall be dermatologically safe when tested as per 1S 4011

Sl No. Characteristics Requirement for
Body Face
Powder Powder
1. Matter insoluble in boiling water, percent by mass, Min. 90.0 90.0

2. Fineness:
a) Residue on 75-micron IS Sieve, percent by mass, Max 2.0 1.0
b) Residue on 150-micron IS Sieve, percent by mass,Max 0.5 0.5
3. Moisture and volatile matter, percent by mass, Max 2.0 3.0

4. pH of aqueous suspension 5.5 to 10.0 5.5 to 9.0

5. Heavy metals (as Pb), parts per million, Max 20 20

6. Arsenic (as As2O3), parts per million, Max 2 2

7. Microbial content / limit

a) Total viable count cfu/g Not more Not more
than 1000 than 1000
b) Gram Negative pathogens Less than 10 Less than
10
 Test for Solubility of Colours

Procedure

1) Take 1g of the material and add 50 ml of water, boil for 15 minutes and filter. The
filtrate shall be colorless or faintly coloured.

2) Take 10 g of the material and add 50 ml of rectified spirit. Boil under reflux for 15 min
and filter. The filtrate shall be colorless or faintly coloured.
 Determination of Matter Insoluble in Boiling water
Limit given in BIS – min. 90% by mass
Procedure

Weigh accurately about 1 g of the material and transfer to a 500 ml beaker. If necessary,
wet the material wth a little rectified spirit. Add to the beaker about 200 ml of water and
boil. Allow to settle and filter the supernatant liquid through a Gooch crucible. Wash the
residue in the beaker with water and transfer completely to the filters. Dry the residue in
the crucible at 105 ± 2°C to constant mass.

Calculation

Matter insoluble in boiling water % by mass = 100×M1

M
where M1= mass in g of the residue, and
M = mass in g of the material taken for the test.
 Determination of Fineness
Limit given in BIS – Residue on 75µ IS sieve for – Body Powder- max. 2% by mass
Facepowder- max. 1% by mass
Residue on 150µ IS sieve for Body powder & face powder- max. 0.5% by mass

Procedure

• Place about 10 g of the material, accurately weighed.

• In the specified IS Sieve wash by means of a slow stream of running tap water and
finally with fine stream from a wash bottle until as much material as would pass through
the sieve has passed.
• In case the material is not easily wetted by water, the washing could be started with a
slow stream of filtered denatured spirit.
• Let the water drain from the sieve and then dry the sieve containing the residue on a
steam bath. Transfer the residue onto a tared watch glass carefully and dry it to constant
mass at 105 ± 2 °C.
Calculation

Material retained on the specified sieve, % by mass = 100×M1

M
where M1= mass in g of the residue retained on the specified sieve, and
M = mass in g of the material taken for the test.
 Determination of Moisture & Volatile Matter
Limit given in BIS – 2% by mass for Body Powder
3% by mass for Face Powder
Procedure

Weigh accurately about 5 g of the material in a porcelain or glass dish, about 6 to 8 cm in

diameter and about 2 to 4 cm in depth. Dry in an air oven at a temperature of 105 ± 2 °C to
constant mass (within ± 5 mg).

Calculation

Moisture and volatile matter, % by mass = 100×M1

M
where M1= loss in mass in g on drying, and
M = mass in g of the material taken for the test.
 Determination of pH of Aqueous Suspension

Limit given in BIS – for Body Powder- 5.5 to 10.0

for Face Powder- 5.5 to 9.0
Procedure

Take 10 g of the material in a 150 ml beaker and add 90 ml of freshly boiled and cooled
water. Stir well to make a thorough suspension. Determine the pH of the suspension
using a pH meter within 5 min of making the suspension. In case of a material which does
not wet, the pH shall be determined on the filtrate.
 Test for Heavy Metals
Limit given in BIS – max. 20ppm for Body powder and Face powder.

Outline of Method - The colour produced with hydrogen sulphide solution is matched
against that obtained with standard lead Solution.

Apparatus – Nesslers Cylinders (50 ml capacity).

Reagents- Dilute Hydrochloride Acid (approx. 5 N)

Dilute Acetic Acid (approx. 1 N)
Dilute Ammonium Hydroxide (approx. 5 N)
Hydrogen Sulphide Solution (standard)

Standard Lead Solution - Dissolve 1.600 g of lead nitrate in water and make up the solution to
1000 ml. Pipette out 10 ml of the solution and dilute again to 1000 ml with water. One millilitre of
this solution contain 0.01 mg of lead (as Pb)
Procedure

Weigh about 2.000 g of material in a crucible and heat on a hot plate and then in a muffle furnace
to ignite it at 600°C to constant mass. Add 3 ml of dilute hydrochloric acid, warm (wait till no
more dissolution occurs) and make up the volume to 100 ml. Filter the solution. Transfer 25 ml of
the filtrate into a Nessler’s cylinder. In the second Nessler’s cylinder, add 2 ml of dilute acetic
acid, 1.0 ml of standard lead solution and make up the volume with water to 25 ml.
Add 10 ml of hydrogen sulphide solution to each Nessler cylinder and make up the volume with
water to 50 ml. Mix and allow to stand for 10 min. Compare the colour produced in the two
Nessler’s cylinders. Blank determination without samples are recommended to avoid errors arising
out of reagents.

Results

The sample may be taken to have passed the test, if the colour developed in the sample
solution is less than that of standard solution.
 Determination of Arsenic
Limit given in BIS – max. 2 ppm, for Body powder and Face powder.

Outline of Method - Arsenic present in a solution of the material is reduced to arsine, which is
made to react with mercuric bromide paper. The stain produced is compared with a standard stain.

Reagents-
• Mixed Acid — Dilute one volume of concentrated sulphuric acid with four
volumes of water. Add 10 g of sodium chloride for each 100 ml of the solution.
• Ferric Ammonium Sulphate Solution — Dissolve 64 g of ferric ammonium
sulphate in water containing 10 ml of mixed acid and make up to one litre.
• Concentrated Hydrochloric Acid – according to IS 265.
• Stannous Chloride Solution — Dissolve 80 g of stannous chloride (SnCl 2
2H2O) in 100 mI of water containing 5 ml of concentrated hydrochloric acid.
Procedure

Carry out the test as prescribed in IS 2088, adding into the Gutzeit bottle, 2 ml of Ferric
ammonium sulphate solution, 0.5 ml of stannous chloride solution and 25 ml of sample solution as
prepared in test for heavy metals.

For comparison, prepare a stain using 0.00 I mg of arsenic

trioxide.
SKIN POWDERS FOR INFANTS
• Skin powder for infants shall consist principally of a finely-powdered free flowing absorbent
innocuous material such as natural talc and may contain mild perfume, as well as other ingredients
consistent with the accepted practice in the cosmetic industry.

• The powder shall essentially be free from colouring matter. It maybe buffered to control pH.

• It shall be free from boric acid.

• The product shall not be manufactured from any carcinogenic ingredients.

• Product shall be dermatologically safe.

• Heavy metals calculated as lead (Pb) and arsenic (as As 2O3) shall not exceed 20 and 2 ppm,
respectively.

• Unless specified otherwise, all the raw materials used in the manufacture of skin powder for
infants shall conform to the requirements prescribed in the relevant Indian Standards where these
exist. Other ingredients shall comply with the provisions of latest version of IS 4707 (Part 2)

• The product package shall display a list of key ingredients in descending order of quantity present.
Sl No. Characteristics Requirement

1. Matter insoluble in boiling water, percent by mass, Min. 90.0

2. Fineness:
a) Residue on 75-micron IS Sieve, percent by mass, Max 2.0
b) Residue on 150-micron IS Sieve, percent by mass,Max 0.5

3. Moisture and volatile matter, percent by mass, Max 2.0

4. pH of aqueous suspension 5.5 to 8.0

5. Heavy metals (as Pb), parts per million, Max 20

6. Arsenic (as As2O3), parts per million, Max 2

7. Microbial content / limit

a) Total viable count cfu/g Not more than 100

b) Gram Negative pathogens Absent

NOTE- Procedure for all Test for Baby Powder is same as Test for Powder.
 Test For Freedom from Boric Acid
According to BIS baby powder sholud not contain boric acid.

Reagents- Concentrated Sulphuric Acid- acc. to IS 266.

Rectified Spirit – acc. to IS 323.

Procedure

Weigh about 1 g of the material in a porcelain or china dish. Add about 2 ml of

concentrated sulphuric acid and stir thoroughly with a glass rod. Then add about 5 ml of
rectified spirit and again stir thoroughly. Ignite and observe the appearance of the flame.

The material shall be considered to be free from boric acid if the flame does not have a
green outer edge .
 FDA, Talcum Powder and Asbestos

● In October 2019 US-FDA found asbestos in one of the

containers of Johnson & Johnson’s baby powder.
● The container was part of a 33,000-bottle batch that the
company voluntarily recalled on Oct. 18, 2019.
● The discovery occurred when the FDA conducted a review
of 43 cosmetic samples and found asbestos contamination
in nine of them.
● For years, scientists and companies have known that many
sources of talc are naturally contaminated with asbestos,
which causes mesothelioma.
● The FDA conducted more tests of cosmetics products in
2022 and did not find asbestos in 50 new samples.
Skin creams
• Creams are the most common types of delivery system used for emollients and moisturizers. They
enable a wide variety of ingredients to be quickly and conveniently delivered to the skin.

• On the base of a structural and functional definition, creams are emulsions of water in oil (oily
creams) or oil in water (vanishing creams), in which the active agent is dispersed between the oil
and water phases according to formula partition coefficient.

• By structural characteristics, creams are opaque, viscous, ranged from non-greasy to mildly greasy
texture and tend to evaporate or be absorbed when rubbed onto the skin.
Creams are classified according to their functions. They are

Cleansing and Cold Creams.

Foundation and Vanishing Creams.

CREAMS Night and Massage Creams

Hand and Body Creams.

All-purpose Creams
s.
no Cleansing Creams s. Cold Cream
. no
.
1. Mineral oil Lubricant
1. White Emollient
Lubricant beeswax
Isoprpyl
2. and
myristate 2. Mineral oil Lubricant
emollient
3. Beeswax emollient 3. Distilled Vehicle
water
Petroleum
4. Lubricant 4. Borax Buffer
jelly
5. Borax Buffer 5. Perfume Odour

6. Water Vehicle 6. Sodium preservati

benzoate ve
Methyl Preservati
7.
paraben ve
 s. Vanishing Cream s. Foundation Cream
no. no.

1. Stearic acid Main ingredient

1. Lanette wax Self
2. Propylene glycol, Humectant emulsifying
glycerin, sorbitol base
2. Stearic acid Lubricant
3. Pot. Hydroxide For Fine texture
3. Distilled water Vehicle
4. Triethanolamine Emulsifying
agent 4. Glycerin Humectant
5. Distilled water Vehicle
5. Powder Base
6. Propyl paraben, methyl Preservative 6. Titanium dioxide Colouring
paraben agent
7. Benzyl alcohol Preservative
7. Sandal wood oil perfume
Requirements
• The skin cream shall be in the form of a thick emulsion or unctuous mass with a pleasant odour. It
shall be white or pigmented or of uniform colour.

• The dyes, colours (pigments, lakes etc.) if used shall comply with the latest version of IS 4707
(Part 1) subject to the provision of schedule Q of Drugs and Cosmetic Act.

• Other ingredients shall comply with the provisions of IS 4707 (Part 2).

• The product shall not be manufactured from any carcinogenic ingredients.

• Product shall be dermatologically safe when tested as per 1S 4011

Requirements

• Heavy metals calculated as lead (Pb) and arsenic (as As 2O3 shall not exceed 20 and 2 ppm,
respectively when tested by the respective method prescribed in Indian Standards.

• The product package shall display a list of key ingredients in descending order of quantity present.

• For Creams based on beeswax and borax, the pH shall be between 5.0-10.0
Sl No. Characteristics Requirement

1. Thermal stability To pass the test

2. pH 4.0 to 9.0

3. Total fat substance content , percent by mass, Min. 5.0

4. Total residue, percent by mass, Min 10

5. Heavy metals (as Pb), parts per million, Max 20

6. Arsenic (as As2O3), parts per million, Max 2

7. Microbial content / limit

a) Total viable count cfu/g Not more than 1000

b) Gram Negative pathogens Less than 10

 Test for Thermal Stability
Apparatus – A humidity chamber/incubator controlled at 60 to 70 percent relative humidity
and 45 ± 1 °C.
Clear glass bottles of around 30 ml capacity with plug and screw on cap for
proper closure

Procedure

With the help of spatula, insert the cream into glass bottle and tap it to settle to the
bottom. Fill up to two third capacity of bottle and insert plug and tighten the cap. Keep the
filled bottle erect inside the incubator at 45 ± 1 °C for 48 h.
The sample shall be taken to have passed the test, if on removal from the incubator
shows no oil separation or any other phase separation.
 Determination of pH
Limit given in BIS – 4.0 to 9.0

Apparatus - A pH meter, preferably equipped with a glass electrode.

Procedure

For Oil-in-Water emulsion creams

Weigh accurately 5 ± 0.01 g of the cream in a 100 ml beaker. Add 45 ml of water and
disperse the cream in it. Determine the pH of the suspension at 27°C using the pH meter.

For Water-in-oil emulsion creams

Weigh 10 g of the cream to the nearest 0.1 g. Add 90 ml of rectified spirit previously
adjusted to pH 6.5 to 7.0. Warm, if necessary to 45°C and stir thoroughly for 15 min. Filter
the alcoholic layer through a filter paper and measure the pH of the filtrate at 27°C using
the pH meter.
 Determination Of Total Fatty Substance Content

Limit given in BIS – min. 5.0% by mass

Principle of Method - The emulsion is broken with dilute mineral acid and the fatty matter
is extracted with petroleum ether. It is weighed after removal of the solvent.

Reagents-
1. Dilute Hydrochloric Acid — 1:1 (v/v).
2. Petroleum Ether (60-80°C)
3. Methyl Orange Indicator Solution — Dissolve O.1 g of methyl orange in 100
ml of water.
4. Sodium Sulphate — Desiccated.
 Determination Of Total Fatty Substance Content
Procedure

• Weigh accurately about 2 g of the material into a conical flask, add 25 ml of dilute
hydrochloric acid, fit a reflux condenser into the flask, and boil the contents until the
solution is perfectly clear.
• Pour the contents of the flask into a 300 ml separating funnel and allow it to cool to room
temperature.
• Rinse the conical flask with 50 ml of petroleum ether in portions of 10 ml. Pour the
petroleum ether rinsings into the separating funnel, shake the separating funnel well and
leave until the layers separate.
• Separate out the aqueous phase and shake it out with 50 ml portions of petroleum ether
twice. Combine all the ether extracts and wash them with water until free of acid (when
tested with methyl orange indicator solution).
• Filter the petroleum ether extracts through a filter paper containing sodium sulphate into a
conical flask which has been previously dried at a temperature of 90 ± 2°C and then
weighed.
 Determination Of Total Fatty Substance Content
• Wash the sodium sulphate on the filter with petroleum ether and combine the
washings with filtrate. Distil off the petroleum ether and dry the material remaining in
the flask at a temperature 90 ± 2°C of to constant mass.

Calculation

Total fatty substance, percent by mass = 100 M1

M2
Where
M1 = mass in g of the residue, and

M2 = mass in g of the material taken for the test.

 Determination of Residue
Limit given in BIS – min. 10% by mass.

Procedure

Weigh accurately about 5 g of the material in a weighed, clean and dry squat form weighing
bottle and dry to constant mass at 105 ± 1 °C. Cool in a desiccator and weigh.

Calculation

Total fatty substance, percent by mass = 100 M1

M2
Where
M1 = mass in g of the residue, and

M2 = mass in g of the material taken for the test.

 Test for Heavy Metals
Limit given in BIS – max. 20ppm

Outline of Method - The colour produced with hydrogen sulphide solution is matched
against that obtained with standard lead Solution.

Apparatus – Nesslers Cylinders (50 ml capacity).

Reagents- Dilute Hydrochloride Acid (approx. 5 N)

Dilute Acetic Acid (approx. 1 N)
Dilute Ammonium Hydroxide (approx. 5 N)
Hydrogen Sulphide Solution (standard)

Standard Lead Solution - Dissolve 1.600 g of lead nitrate in water and make up the solution to
1000 ml. Pipette out 10 ml of the solution and dilute again to 1000 ml with water. One millilitre of
this solution contain 0.01 mg of lead (as Pb)
Procedure

Weigh about 2.000 g of material in a crucible and heat on a hot plate and then in a muffle furnace
to ignite it at 600°C to constant mass. Add 3 ml of dilute hydrochloric acid, warm (wait till no
more dissolution occurs) and make up the volume to 100 ml. Filter the solution. Transfer 25 ml of
the filtrate into a Nessler’s cylinder. In the second Nessler’s cylinder, add 2 ml of dilute acetic
acid, 1.0 ml of standard lead solution and make up the volume with water to 25 ml.
Add 10 ml of hydrogen sulphide solution to each Nessler cylinder and make up the volume with
water to 50 ml. Mix and allow to stand for 10 min. Compare the colour produced in the two
Nessler’s cylinders. Blank determination without samples are recommended to avoid errors arising
out of reagents.

Results

The sample may be taken to have passed the test, if the colour developed in the sample
solution is less than that of standard solution.
 Determination of Arsenic
Limit given in BIS – max. 2 ppm.

Outline of Method - Arsenic present in a solution of the material is reduced to arsine, which is
made to react with mercuric bromide paper. The stain produced is compared with a standard stain.

Reagents-
• Mixed Acid — Dilute one volume of concentrated sulphuric acid with four
volumes of water. Add 10 g of sodium chloride for each 100 ml of the solution.
• Ferric Ammonium Sulphate Solution — Dissolve 64 g of ferric ammonium
sulphate in water containing 10 ml of mixed acid and make up to one litre.
• Concentrated Hydrochloric Acid – according to IS 265.
• Stannous Chloride Solution — Dissolve 80 g of stannous chloride (SnCl 2
2H2O) in 100 mI of water containing 5 ml of concentrated hydrochloric acid.
Procedure

Carry out the test as prescribed in IS 2088, adding into the Gutzeit bottle, 2 ml of Ferric
ammonium sulphate solution, 0.5 ml of stannous chloride solution and 25 ml of sample solution as
prepared in test for heavy metals.

For comparison, prepare a stain using 0.00 I mg of arsenic

trioxide.
Sunscreen
Sunscreens are defined as substances that protect the skin from the harmful effects of solar UV
radiation by absorbing, reflecting, scattering, or otherwise deflecting UV photons, avoiding their
absorption by the components of the skin.

Sunscreen-mediated photoprotection is concerned with the reduction of exposure to UVR,

specifically UVB and UVA, primarily from the sun.

There are two categories of sunscreen agents:

. Organic Inorganic
• The organic sunscreens are referred to as • The inorganic sunscreens are commonly
soluble or chemical sunscreens. known as physical, mineral, insoluble,
• Chemical sunscreens absorb high-energy UV natural or nonchemical
rays • Physical blockers reflect or scatter light
Sunscreening agents
contain titanium dioxide
(TiO2), kaolin, talc, zinc
oxide (ZnO), calcium
carbonate, and magnesium
oxide.

Newer chemical
compounds, such as
bemotrizinol, avobenzone,
bisoctizole, benzophenone-
3 (BZ-3, oxybenzone), and
octocrylene, are broad-
spectrum agents
Sun Protection Factor (SPF)
Sunscreens are made in a wide range of SPFs.The SPF value indicates the level of
sunburn protection provided by the sunscreen product.

Higher SPF values (up to 50) provide greater sunburn protection.

SPF values only indicate a sunscreen's UVB protection. Broad Spectrum SPF, they will
indicate protection from both UVA and UVB radiation.

SPF is measured using the following formula:

SPF = MED of protected skin

MED of unprotected skin
(MED = minimal erythemal dose).

.
 Regulatory guideline
In India, there are no industry guidelines for standardizing sunscreen agents and there is no detailed
list of approved products. The Indian regulatory agency's official website lists only two combination
products as approved drugs.
COMBINATION APPROVED BY PROTECTION GRADE OF UVA (PA)
INDIAN REGULATORY AUTHORITY* APPROVED CONCENTRATION (%)
Octinoxate + Avobenzone +
Oxybenzone + Octocrylene + Zinc
7.5+2+3+3+2
Oxide lotion (approved on March 19,
2009)
Octinoxate + Avobenzone +
Oxybenzone + Titanium dioxide lotion 7.5+3+3+2
(approved on March 23, 2009)
 COMPOUNDS AVAILABLE IN INDIA† CONCENTRATION (%) SPF
Agents which are manufactured by
pharmaceutical companies and are
available in India. Most of the products Bis-Ethylhexyloxyphenol Methoxyphenyl
Triazine ((Tinosorb S, Bemotrizinol)+
available are combination products. Butyl Methoxydibenzoylmethane
((Tinosorb M- active, Avobenzone)+
2+2+5+2+7 30
Methylene Bis-Benzotriazolyl
Tetramethylbutylphenol ( Bisoctrizole )+
Benzophenone-3 (Uvinul M40)+
Octocrylene (Uvinul N539T)

Bis-Ethylhexyloxyphenol Methoxyphenyl
Triazine + Butyl
Methoxydibenzoylmethane Methylene
Bis-Benzotriazolyl 5+2+7+3+10 50
Tetramethylbutylphenol ((Tinosorb M,
active) + Benzophenone-3 (Uvinul
M40)+ Octocrylene (Uvinul N539T)

Tinosorb M; Octinoxate; Octyl triazone

60
[EHT/Uvinul T150] - S3 Complex

Octinoxate +Avobenzone + Oxybenzone

7.5 +2+3+3+2 50+
+ Octocrylene + Zinc Oxide

Oxybenzone + OMC + Tinosorb M 3+5+8 30

LIST OF PERMITTED UV FILTERS WHICH COSMETIC PRODUCTS MAY
CONTAINS (IS- 4707-2)
S.NO SUBSTANCE MAX. AUTHORIZED OTHER LIMITATION CONDITIONS
. CONC. AND OF USE AND
REQUIREMENTS WARNINGS
1 4-Aminobenzoic 5 PERCENT _
acid
2 Oxybenzone (INN) 10 percent _ Contains
oxybenzone
(Protects the
skin from the
sun )

3 2-Ethylhexyl 5 percent _
salicylate (Oc tyl-
salicy late)
4 3-Benzylidene 2 percent _
camphor (3-
Benzylidene
Camphor)
5 TItanium dioxide 25 percent _
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN IN EXCEPT SUBJECT TO
RESTRICTIONS AND CONDITIONS LAID DOWN (4707-2)
S.NO. Substance Field of Application Max.Authorized Other Limitations and
Conc. Requirement

1 Boric acid, borates and Talc 5% 1) Not to be used in

tetraborates products for children under
3 yrs of age
2) Not to be used on
peeling or irritated skin if
the concentration of free
soluble borates exceeds
1.5 percent

2 Hydrogen peroxide Skin care preparation 4%

3 Zinc 4-hydroxybenzene Deodorants, 6%

sulphonate antiperspirants &
astringent lotion
4 Talc: hydrated Mg silicate Powdery products
intended to be used for
children under 3 yrs of
age
LIST OF DYES, COLOURS AND PIGMENTS PERMITTED TO BE USED IN
COSMETICS (4707-1)
SNO. Common name of the Colour Index Number colour
colour
1 Sunset yellow FCF 15985 Yellow
2 Tartrazine 19140 Lemon yellow

3 Light Green SF Yellowish 42095 Light green

4 Tetrachlorofluorescein K 45366 Orange

5 Helindone Pink CN. 73360 Pink

6 Flaming Red 12085 Red
7 Toluidine Red. . 12120 Red
8 Orange G. 16230 Orange
9 Dichlorofluorescein 45365 Green
10 Indigo. 73000 Blue
 References

● Yousef H, Alhajj M, Sharma S. Anatomy, Skin (Integument), Epidermis. [Updated 2022 Nov 14]. In:
StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK470464/
● Latha MS, Martis J, Shobha V, Sham Shinde R, Bangera S, Krishnankutty B, Bellary S, Varughese S, Rao P,
Naveen Kumar BR. Sunscreening agents: a review. J Clin Aesthet Dermatol. 2013 Jan;6(1):16-26. PMID:
23320122; PMCID: PMC3543289.
● Wound healing applications of creams and “smart” hydrogels - Scientific Figure on ResearchGate. Available
from: https://www.researchgate.net/figure/Summary-of-cream-types-and-their-applications_tbl1_351720173
DOI:10.1111/exd.14396
● https://www.fda.gov/drugs/understanding-over-counter-medicines/sunscreen-how-help-protect-your-skin-
sun#label
● Textbook of Cosmetic Formulation : Creams https://www.pharmacy180.com/article/classification-of-
creams-831/
 BIS standard

● IS- 4707 part 1 - Classification of cosmetics raw materials and adjuncts

(dyes, colour and pigments)
● IS- 4707 part 2 - Classification for cosmetic raw materials and adjuncts
● IS 3959 – Skin Cream
● IS 5339 – Skin powder for infant
● IS 6608 – Skin creams
 Thank you!
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Created by-
STUTI GUPTA