refer US-FDA

1. PRESENTED BY :
PRAVIN PATEL
(PE/2013/310)
M.S PHARMACEUTICS

2. A cosmeceutical is an ingredient with medicinal
properties, which manifests beneficial topical
actions and provides protection against
degenerative skin conditions
The term cosmeceutical was
coined in 1980 by the
dermatologist Albert kligman

3. The FD&C Act
does not recognize
any such category
as "cosmeceuticals.“
 A product can be
a drug, a cosmetic,
or a combination of
both, but the term
"cosmeceutical" has
no meaning under
the law.
www.fda.gov

4. According to FD&C Act.
COSMETICS
“Articles intended to be rubbed, poured, sprinkled,
or sprayed on, introduced into, or otherwise applied
to the human body...for cleansing, beautifying,
promoting attractiveness, or altering the appearance"
DRUG
"Articles intended for use in the
diagnosis, cure, mitigation, treatment, or
prevention of disease" and "articles (other than
food) intended to affect the structure or any
function of the body of man or other animals

5. International Regulatory Policies
Cosmetics
No extensive testing like drugs
Less time consuming and cost
Prohibit the false advertisements.
Cosmeceuticals
Cosmecuticals are not regulated by the U.S.FDA are not
subject to premarket requirements for proof of safety or
efficacy.
Cosmecuticals products
in vitro studies using silicone replicas of skin
clinical trials (supported by the cosmetic companies
themselves)
The rigorous testing required for pharmaceuticals, is not
mandatory for cosmeceuticals products

6. Cosmetic versus drug
A deodorant is a cosmetic but an antiperspirant is a drug
A shampoo is a cosmetic but an antidandruff shampoo is a drug
A toothpaste is a cosmetic but an anticaries toothpaste is drug
A mouthwash is cosmetic but an antigingivitis mouth wash is a drug
A suntan product is a cosmetic but a sunscreen product is a drug
A skin moisturizer is a cosmetic but a wrinkle remover is a drug
A skin product to hide acne is cosmetic but an antiacne product is a drug
An antibacterial deodorant soap is a cosmetic but an antibacterial antiinfective soap is a drug

7. List of common ingredient used in cosmeceuticals
•UV protection
•Exfoliants
•Alpha hydroxy acids
Lactic acid
Glycolic acid
•Beta hydroxy acids
•Retinoids
•Moisturizers
•Antioxidants
•Peptides
•De-pigmenting agents

8. Uv protection
UVA wavelengths penetrate deeply into the dermis, causing skin
to wrinkle.
UVB radiation is associated with many skin cancers.
The SPF number on sun blockers only applies to UVB protection
and has no connection with UVA protection.
A SPF number of 30 is recommended for daily use.
Higher numbers do not proportionately increase protection.
Exfoliants
Exfoliants remove dead cells and the outer layers of
thickened skin, encouraging skin turnover.
Alpha hydroxy acids
Softens fine wrinkles, lightens pigmentation spots,
generally tightens and improves skin texture.
Makes skin look healthier and more radiant.

9. Retinoids
Treats mild to moderate acne and photo-damaged
skin, removes dead surface cells, Claims to build
collagen, regenerate the skin’s elasticity.
Moisturizers
Moisturizers smooth the surface of the skin,
lubricate its outer layers, and lock in moisture.
Antioxidants
Antioxidants, the ingredients meant to
defend against free radical damage.
Vitamin A & C
Resveratrol
Green tea
Co-enzyme Q-10
Algae

10. Peptides
peptides that may stimulate skin
metabolism and repair, while others
may inhibit hyperpigmentation,
slow the breakdown of collagen
Eg: Argireline
Depigmentation agents
It acts by inhibiting conversion of
tyrosine to melanin
Eg: Hydroquinone, aloesin,
arbutin, azelaic acid, glycolic acid

11. Why Does Skin Age??
Aging results from cumulative damage to tissues
that overwhelm the body's natural ability to repair
them. The tell tale signs of aging on the skin include
discoloration, wrinkles, and texture loss
These effects result from
•Genetically programmed chronological aging
•Photoaging - sun exposure
•Environmental and lifestyle factors – damage by
chemicals,
pollutants,
smoking, etc.

12. What are Sunscreens?
Certain synthetic organic substances or sunscreens have
molecular structures that are capable of "filtering out" the
harmful UV rays by mechanisms including absorption,
reflection or diffusion.
Examples include avobenzone, aminobenzoic acid, titanium
oxide, zinc oxide and others.
Such ingredients appear in the FDA monograph on
sunscreen agents. Sunscreens are regulated as over the
counter drugs by the FDA.
The efficacy of sunscreens is measured as SPF (sun
protection factor).

13. Photoaging - sun exposure
Effect of UV Rays
UV damage is manifested as
• sunburn,
• skin discoloration
•texture loss.
UV rays also trigger skin aging through:
Free radical reactions and oxidative stress.
Increased activity of enzymes such as collagenase
and elastase that are catalyzed by metal ions.

14. The results are:



Abnormal cross linking of Collagen
fibers
Scar tissue build up and visible
wrinkles and skin discoloration
Ravages of chronological aging are
accelerated

15. The sunscreens listed in the FDA OTC monograph
Drug Name
Concentration %
Absorbance
Aminobenzoic acid
up to 15
UVB
Avobenzone
2-3
UVA I
Cinoxate
up to 3
UVB
Dioxybenzone II
up to 3
UVB, UVA I & II
Homosalate
up to 15
UVB
Menthyl anthranilate
up to 5
UVA II
Octyl methoxycinnamate
up to 7.5
UVB
Octisalate
up to 5
UVB
Oxybenzone
up to 5
UVB
Padimate O
up to 8
UVB
Phenylbenzimidazole sulfonic acid
up to 4
UVB
Sulisobenzone
up to 10
UVB, UVA II
Titanium dioxide
2-25
Physical
Trolamine salicylate
up to 12
UVB
Zinc oxide
2-20
Physical

16. Several natural extracts protect the skin from the
damaging effects of UV rays:
•Tetrahydrocurcuminoids
•SabiWhite
•Green tea Extract
•Sesame antioxidants
•Umbelliferin
•Xylosin
•Rosemary extract
•Rosmarinic acid
•Lupeol
•Arjunolic acid

17. Product Safety Testing
Testing needs are determined by the company
marketing the product .May include:
•In vitro testing
•Cumulative Irritation testing
•Repeat Insult Patch Tests (RIPT)
•Sensitization
•Ocular Irritation
•Facial Sting
•Phototoxicity
•Photoallergy
•Dermal irritation
•Acnegenicity

18. Dermal irritation
Defined as the production
of “reversible damage of
the skin following the
application of a test
substance for up to 4
hours”. Tests used to
study dermal irritation:
1. EPISKIN™ human
skin model.
2. EpiDerm™ human
skin model.
3. PREDISKIN™
human skin model.
4. Pig ear test.

19. Examples of Instrumental Measurements
Parameter
Instrument
Moisturization
Conductance/Impedance
Skin barrier function
TEWL(Transepidermal Water Loss)
Skin texture
Topography
Skin elasticity
Elastometer
Skin thickness
Ultrasound
Blood flow
Laser Doppler
Sebum (oiliness)
Sebumeter
Color
Chromameter

20. Advantage of cosmeceuticals
•Safe for long-terms use
•Promote beauty throught health and wellness of skin
•cosmeceuticals with natural ingredients are preferred.

21. REFERENCE
1) Kligman AM. Cosmetics A dermatologists look to the future:
Promises and problems. Dermatol Clin 2000; 18:699-709.
2) Food & Drug Administration (FDA)
http://www.fda.gov/
3)
Cosmetic, Toiletry,
http://www.ctfa.org
and
Fragrance
Association
(CTFA)
4) Thornfeldt C. Cosmeceuticals containing herbs: fact, fiction, and
future. Dermatol Surg. Jul 2005;31(7 Pt 2):873‐80;
5) Amer.M, Maged M. Cosmeceuticals versus pharmaceuticals.
Clinics in Dermatology
2009; 27:428–430.