COSMETICS AND COSMECEUTICALS

1. COPS DSU
DEPARTMENT OF PHARMACEUTICS
SUBMITTED TO :
Dr.MANJULA.D
ASST. PROFESSOR
DEPARTMENT OF PHARMACEUTICS
PRESENTED BY:
SAGAR.G
M. PHARM, 2nd SEM
DEPARTMENT OF PHARMACEUTICS
COSMETICS AND COSMECEUTICALS
SUNSCREEN CLASSIFICATION AND
REGULATORY ASPECTS

2. COPS DSU
DEPARTMENT OF PHARMACEUTICSCOSMETICS AND COSMECEUTICALS
A preparation (such as a lotion) applied to the skin to prevent sunburn (as by
chemically absorbing ultraviolet radiation)
A substance that helps protect the skin from the sun's harmful rays.
Sunscreens reflect, absorb, and scatter both ultraviolet A and B radiation to
provide protection against both types of radiation. Using lotions, creams, or
gels that contain sunscreens can help protect the skin from premature aging
and damage that may lead to skin cancer.
Sunscreen, also known as sunblock and suntan lotion, is a lotion, spray, gel
or other topical product that absorbs or reflects some of the sun's ultraviolet
radiation and thus helps protect against sunburn. Diligent use of sunscreen can
also slow or temporarily prevent the development of wrinkles, moles and sagging
skin.
SUNSCREEN

3. COPS DSU
DEPARTMENT OF PHARMACEUTICSCOSMETICS AND COSMECEUTICALS
CLASSIFICATION OF SUNSCREENS
● Depending on the mode of action, sunscreens can be classified into physical
sunscreens (i.e., those that reflect the sunlight) or chemical sunscreens
(i.e., those that absorb the UV light).
● Physical sunscreens act as a shield and reflect both UVA and UVB light and
contain ingredients such as titanium dioxide and zinc oxide. Physical
sunscreens are a good choice for people with allergies to chemical
sunscreens
● Chemical sunscreens absorb UVA or UVB rays and contain ingredients such
as avobenzone and benzophenone.
● Chemical sunscreens often contain UVB-absorbing chemicals only; however,
there are some chemical sunscreens that contain both UVB and UVA
absorbers.
● A new over-the-counter sunscreen was recently developed that contains
mexoryl, an ingredient that offers protection from both UVA and UVB
radiation.
● Broad-spectrum sunscreens, which contain both chemical and physical
ingredients, are also available.

4. COPS DSU
DEPARTMENT OF PHARMACEUTICSCOSMETICS AND COSMECEUTICALS
Classification of Sunscreens According to
Application
● Depending on their intended application, sunscreens may be classified as follows.
● (1) Sunburn preventive agents are defined as sunscreens which absorb 95 per
cent or more of UV radiation within wavelengths 290-320 nm.
● (2) Suntanning agents are defined as sunscreens which absorb at least 85
per cent of UV radiation within the wavelength range from 290 nm to 320
nm but which transmit UV light at wavelengths longer than 320 nm and
produce a light transient tan. These agents will produce some erythema but
without pain.
● (3) Opaque sunblock agents aim to provide maximum protection in the form of a
physical barrier.
● Titanium dioxide and zinc oxide are the most frequently used agents in this
group. Titanium dioxide reflects and scatters practically all radiation in the UV
and visible range (290-777 nm), thereby preventing or minimising both sunburn
and suntan.

5. COPS DSU
DEPARTMENT OF PHARMACEUTICSCOSMETICS AND COSMECEUTICALS
REGULATORYASPECTS OF SUNSCREENS
● Mismatches between skin pigmentation and modern lifestyle continue to
challenge our skin. One of our responses to these challenges is the development
and use of sunscreens.
● The management of sunscreens has to balance their protective effect against
erythema, photo carcinogenesis and photo ageing owing to the potential
toxicity of the ultraviolet (UV) filters for humans and the environment.
● In 2009, the Therapeutic Goods Administration of Australia updated a review of
sunscreen safety studies and concluded: "The potential for titanium dioxide
(TiO2) and zinc oxide (ZnO) nanoparticles in sunscreens to cause adverse effects
depend primarily upon the ability of the nanoparticles to reach viable skin cells.
● To date, the current weight of evidence suggests that TiO2 and ZnO
nanoparticles do not reach viable skin cells.

6. COPS DSU
DEPARTMENT OF PHARMACEUTICSCOSMETICS AND COSMECEUTICALS
● Sunscreen ingredients typically undergo extensive review by government
regulators in multiple countries, and ingredients that present significant
safety concerns (such as PABA) tend to be withdrawn from the consumer
market
● Concerns have also been raised about potential vitamin D deficiency arising
from prolonged use of sunscreen. Typical use of sunscreen does not usually
result in vitamin D deficiency; however, extensive usage may.

7. COPS DSU
DEPARTMENT OF PHARMACEUTICSCOSMETICS AND COSMECEUTICALS
● Sunscreen labeling standards have been evolving in the United States since
the FDA first adopted the SPF calculation in 1978. The FDA issued a
comprehensive set of rules in June 2011, taking effect in 2012–2013, designed
to help consumers identify and select suitable sunscreen products offering
protection from sunburn, early skin aging, and skin cancer.
● To be classified as "broad spectrum", sunscreen products must provide
protection against both UVA and UVB, with specific tests required for both.
● Claims of products being "waterproof" or "sweatproof" are prohibited, while
"sunblock" and "instant protection" and "protection for more than 2 hours"
are all prohibited without specific FDA approval.
● "Water resistance" claims on the front label must indicate how long the
sunscreen remains effective and specify whether this applies to swimming
or sweating, based on standard testing.
United States

8. COPS DSU
DEPARTMENT OF PHARMACEUTICSCOSMETICS AND COSMECEUTICALS
● Sunscreens must include standardised "Drug Facts" information on the
container. However, there is no regulation that deems it necessary to
mention whether the contents contain nanoparticles of mineral
ingredients.
● The EU has stricter regulation against the use of nanoparticles, and in
2009 introduced labeling requirements for nanoparticle ingredients in
certain sunscreens and cosmetics.

9. COPS DSU
DEPARTMENT OF PHARMACEUTICSCOSMETICS AND COSMECEUTICALS
EUROPEAN UNION
● Sunscreen products protect against UV radiation. They are cosmetics according
to Regulation (EC) No 1223/2009. The efficacy of sunscreen products, and the
basis on which this efficacy is claimed are important public health-issues.
● In particular:
● Products should contain protection against all dangerous UV radiation.
● An indication of the efficacy of sunscreen products should be simple,
unambiguous, and meaningful; and it should be based on standardised,
reproducible criteria.
● Labels and claims should provide sufficient information to help consumers
choose the appropriate product and apply it correctly.
● The Recommendation on the efficacy of sunscreen products and the claims
made relating to them, adopted in 2006, addresses these issues and sets
out the:
● claims which should not be made in relation to sunscreen products.
● precautions to be observed including application instructions.

10. COPS DSU
DEPARTMENT OF PHARMACEUTICSCOSMETICS AND COSMECEUTICALS
● minimum efficacy standard for sunscreen products in order to ensure a
high level of protection of public health..
● simple and understandable labeling to assist in choosing the appropriate
product
● The protection against UV radiation offered by sunscreens was recently
standardised in the European Union (EU) based on international harmonisation
of measurement techniques.
● The UV filters in sunscreens have long been authorised for use by the EU
authority on the basis of data from studies on acute toxicity, subchronic and
chronic toxicity, reproductive toxicity, genotoxicity, photogenotoxicity,
carcinogenicity, irritation, sensitisation, phototoxicity and photosensitisation as
well as on environmental aspects.

11. COPS DSU
DEPARTMENT OF PHARMACEUTICSCOSMETICS AND COSMECEUTICALS
● Harry’s Cosmeticology, Seventh Edition
● Wikipedia
● Hand book of cosmetic science and technology
Third edition sun protection and sunscreen 223-329
REFERENCES :

12. COPS DSU
DEPARTMENT OF PHARMACEUTICS
THANK
YOU
COSMETICS AND COSMECEUTICALS