BP809ET

Unit I

Introduction : classification of cosmetic and cosmeceutical

products, definition of cosmetics as per Indian and EU
regulations, evolution of cosmeceuticals from cosmetics,
cosmetics as quasi and OTC drugs
Cosmetic excipients : surfactants, rheology modifiers,
humectants, emollients, preservatives,
classification and application
Skin : basic structure and function of skin
Hair : basic structure of hair, hair growth cycle
Oral Cavity : common problem associated with teeth and gums

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 BP809ET

Unit -1 Lecture 1

Introduction : classification of cosmetic and

cosmeceutical products, definition of
cosmetics as per Indian and EU regulations,
evolution of cosmeceuticals from cosmetics,
cosmetics as quasi and OTC drugs
 COSMETICS
• The term cosmetics have been derived from the
term “COSMETIKOS” which means the skill to
decorate.

History of cosmetics beginning with the Ancient

Egyptians 5000 years ago
 Definition
• As per Drugs & Cosmetics Act, 1940 (India)
A cosmetic is defined as any article intended to
be rubbed, poured, sprinkled or sprayed on, or
introduced into, or otherwise applied to, the
human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or
altering the appearance. It also includes any
article intended for use as a component of
cosmetic.
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 Definition
• As per Food, Drug and Cosmetic (FDC) Act,
1938 (US)
A cosmetic is defined as an article intended to
be rubbed, poured, sprinkled, or sprayed on,
introduced into, or otherwise applied to the
human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or
altering the appearance without affecting
structure or function

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Definition
• As per article 1 of EU Cosmetics directive 93/35/EEC,
1993 of European Union law (European Union)
A ‘cosmetic product’ shall mean any substance or
preparation intended to be placed in contact with the
various external parts of the human body epidermis,
hair system, nails, lips and external genital organs or
with the teeth and the mucous membranes of the oral
cavity with a view exclusively or mainly to cleaning
them, perfuming them, changing their appearance
and/or correcting body odours and/or protecting
them or keeping them in good condition
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Definition
• Cosmeceutical, on the other hand, is a cosmetic
product that is purported to have therapeutic action
capable of affecting the skin positively beyond the
time of its application
• Cosmeceuticals are hybrid category of products
between cosmetics and pharmaceuticals
• A cosmeceutical exerts a 'therapeutic benefit‘ and
exhibits an ability to improve not function, not just
skin appearance

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CAN A PRODUCT BE
BOTH A COSMETIC
AND A DRUG?

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 Revision Question

The term cosmetics means skills to

decorate.

A. TRUE
B. FALSE

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From cosmetics to cosmeceuticals

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From cosmetics to cosmeceuticals

• The term “cosmeceutical” was introduced by dermatologist Dr

Albert Kligman in 1984
• It is derived from a combination of the words cosmetic and
pharmaceutical.
• Cosmeceuticals like cosmetics, are applied topically but
contain active ingredients that have an effect on body cell
function.
• In some cases, their action is limited to the surface (such as
exfoliants), while others can penetrate to deeper levels,
either enhancing or limiting normal functions.

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 Revision Question

The term cosmeceuticals is introduced by

______ in the year ______

A. Chemist, 1964
B. Pharmacist, 1974
C. Dermatologist, 1984

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From cosmetics to cosmeceuticals
• The category of cosmeceutical products is still not formally recognized
by the CDSCO in India, United States Food and Drug Administration
(US-FDA) or the European Union (EU).
• But as per the definitions, in India, Europe and Japan, cosmeceuticals
can be regarded as a subclass of cosmetics; however, in the United
States cosmeceuticals can only be regarded as a subclass of drugs
• The Japanese authorities call cosmeceuticals as ‘quasi-drugs.’ They
permit cosmetics to contain pharmacologically active ingredients,
provided that the medicinal effects are mild and the products safety
has been demonstrated.
• In Thailand they are called 'controlled cosmetics' while in Hong Kong
as 'cosmetic-type drugs.‘
• The regulations of cosmeceuticals have not been harmonized
between the USA, European, Asian and other countries.
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From cosmetics to cosmeceuticals
Cosmeceuticals as a Subclass of Cosmetics (Europe and Japan) and as
a Subclass of Drugs (U.S.)

Cosmetic Cosmeceutical Drug

Appearance + + +
enhancement
Intended effect in - + +
skin disease

Intended effect in - + +
mild skin disorder

Side effects - + +

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 Revision Question

Cosmeceuticals are also known as Quasi-

drugs in __________

A. Thailand
B. India
C. Japan
D. Hong Kong
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 Revision Question

Identify

A. Cosmetics
B. Cosmeceuticals
C. Drug

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 Revision Question

Identify

A. Cosmetics
B. Cosmeceuticals
C. Drug

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 Revision Question

Identify

A. Cosmetics
B. Cosmeceuticals
C. Drug

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 Revision Question

Identify

A. Cosmetics
B. Cosmeceuticals
C. Drug

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 COSMETICS AS QUASI DRUGS
 Quasi drugs are considered as a category of beauty products
in Japan and South Korea.
 The other category of beauty products is cosmetics. There is a
thin line between drugs and cosmeceuticals, which can be
considered as quasi-drugs.
 Since their benefits are not as strong as drugs, they are
categorized separately.

 Quasi drugs are generally classified into two types:

 GROUP 1

 GROUP 2
 COSMETICS AS QUASI DRUGS
GROUP 1
Items used for sanitary purposes such as sanitary pads, tampons and menstrual
pads
The textiles used for manufacturing masks such as dust and surgical masks.
Wet wipes for oral hygiene.
Sanitary products used for protection, preservatives, and treatment of affected
areas that includes different kinds of bandages, plastics bandages.

GROUP 2
Odour inhibitors like toothpaste, antiperspirants and bath products.
Hair care products that are only meant for external usage.
Products that don’t contain nicotine for those who smoke.
Ointments and anti-inflammatory products for external use.

The registration process for quasi drugs is systematic and has few protocols to
qualify.
But the safety and efficacy data needs to be submitted.
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 COSMETICS AS OTC DRUGS
OTC drugs are medicines sold directly to the patients without
prescription from healthcare professional.

Cosmeceuticals are sold as OTCs in US. This is applicable to

products that meet the definitions of both cosmetics and drugs.

Certain claims may cause a product to be considered a drug, even

if the product is marketed as a cosmetic.

For example, in the U.S, antidandruff shampoos and sunscreen

products are considered to be OTCs.

OTCs must be manufactured and controlled in accordance with

cGMP requirements for pharmaceuticals for human consumption.
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•Cosmetics

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 SKIN COSMECEUTICALS
• Cosmeceuticals are the cosmetic products that have medicinal or
drug- like benefits are able to affect the biological functioning of
skin owing to type of functional ingredients they contain.
• These are skin-care products that go beyond coloring and adorning
the skin. Such products improve the functioning/texture of the
skin by encouraging collagen growth, by combating harmful
effects of free radicals, thus maintaining keratin structure in
good condition and making the skin healthier.
• Example: OLAY vitamin line, which includes vitamins A, C,
D, E, selenium, and lycopene, pycnogenol plus zinc and copper,
is a well-known skin care line.
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