PRESENTED BY :
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
The FD&C Act
does not recognize
any such category
A product can be
a drug, a cosmetic,
or a combination of
both, but the term
no meaning under
According to FD&C Act.
“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"
"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
International Regulatory Policies
No extensive testing like drugs
Less time consuming and cost
Prohibit the false advertisements.
Cosmecuticals are not regulated by the U.S.FDA are not
subject to premarket requirements for proof of safety or
in vitro studies using silicone replicas of skin
clinical trials (supported by the cosmetic companies
The rigorous testing required for pharmaceuticals, is not
mandatory for cosmeceuticals products
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
List of common ingredient used in cosmeceuticals
•Alpha hydroxy acids
•Beta hydroxy acids
UVA wavelengths penetrate deeply into the dermis, causing skin
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 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.
Treats mild to moderate acne and photo-damaged
skin, removes dead surface cells, Claims to build
collagen, regenerate the skin’s elasticity.
Moisturizers smooth the surface of the skin,
lubricate its outer layers, and lock in moisture.
Antioxidants, the ingredients meant to
defend against free radical damage.
Vitamin A & C
peptides that may stimulate skin
metabolism and repair, while others
may inhibit hyperpigmentation,
slow the breakdown of collagen
It acts by inhibiting conversion of
tyrosine to melanin
Eg: Hydroquinone, aloesin,
arbutin, azelaic acid, glycolic acid
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
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
Photoaging - sun exposure
Effect of UV Rays
UV damage is manifested as
• skin discoloration
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.
The results are:
Abnormal cross linking of Collagen
Scar tissue build up and visible
wrinkles and skin discoloration
Ravages of chronological aging are
The sunscreens listed in the FDA OTC monograph
up to 15
up to 3
up to 3
UVB, UVA I & II
up to 15
up to 5
up to 7.5
up to 5
up to 5
up to 8
Phenylbenzimidazole sulfonic acid
up to 4
up to 10
UVB, UVA II
up to 12
Several natural extracts protect the skin from the
damaging effects of UV rays:
•Green tea Extract
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)
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
2. EpiDerm™ human
human skin model.
4. Pig ear test.
Examples of Instrumental Measurements
Skin barrier function
TEWL(Transepidermal Water Loss)
Advantage of cosmeceuticals
•Safe for long-terms use
•Promote beauty throught health and wellness of skin
•cosmeceuticals with natural ingredients are preferred.
1) Kligman AM. Cosmetics A dermatologists look to the future:
Promises and problems. Dermatol Clin 2000; 18:699-709.
2) Food & Drug Administration (FDA)
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