The document discusses cosmetics that also function as over-the-counter (OTC) drugs. It provides examples of cosmetic products that contain active pharmaceutical ingredients and have physiological effects, such as anti-dandruff shampoos, fluoride toothpastes, sunscreens containing sun protection factors, and deodorants containing antiperspirant agents. It explains that such cosmetic products are regulated as both cosmetics and drugs and must meet requirements for both types of products, including FDA approval for the drug component. Manufacturers must validate that these "cosmeceutical" products are safe and effective for their intended dual uses.

1. Project Work
on
Cosmetics & Cosmeceuticals
(Introduction, Classification & Evolution)
Session (2020-21)
Ashoka Institute of Technology & Management
ASHOKA ENGINEERING CHAURAHA, PAHARIA, SARNATH,
Varanasi, UP 221007
Affiliated to DR. A.P.J. ABDUL KALAM TECHNICAL UNIVERSITY
SUBMITTED TO - SUBMITTED BY -
Mrs.Swapnil Pandey Brijesh Kumar
B. pharm 4th Year
(1864150015)

2. DECLARATION
I, “Brijesh Kumar” Student of B.PHARMA declare that the project titled ‘’ Cosmetic Science
Project Work‘’ which is submitted by me to Department of pharmacy, ASHOKA INSTITUTE OF
TECHNOLOGY AND MANAGEMENT affiliated to Dr. A.P.J. ABDUL KALAM TECHNICAL
UNIVERSITY.
Candidate Signature

3. CERTIFICATE
This is to certify that this project report entitled “Cosmetic Science Project
Work” submitted to Ashoka Institute of Technology and Management,
Varanasi is a record of work done by Brijesh Kumar under the
supervision of Assistant Professor Mrs. Swapnil Pandey.
Mrs. Swapnil Pandey
Assistant Professor
(Ashoka Institute and Technology
and Management, Varanasi)
Date : 20/05/2022

4. ACKNOWLEDGEMENT
I have taken efforts in this project. However, it would have been possible
without the kind support and help of many individuals. It is indeed a great
pleasure to work on this project and presenting this report to my department.
This project had provided me a good exposure to the real world problem and
also a solution to that.
I would like to pay my heartiest thanks to Dr.Sarika Srivastava, Director of
AITM & Dr.Brijesh Singh, Principal of B.Pharma Department, AITM who
provided me such a wonderful opportunity to pursue my mini project on such
an interesting topics. My heartfelt thanks go to all other faculties who
provided valuable suggestions and kind co-operation. I would like to thanks
our project guide Mrs. Swapnil Pandey , for importing her valuable guidance
and support. She has not only provided suggestions but also rectified my
problems whenever I have faced any problems.
I would like to express my special gratitude and thanks to persons who
rendered their assistance directly or indirectly. I would like to express my
gratitude towards my parents & friends for their kind co-operation and
encouragement which help me in this project.

5. Contents
1. Cosmetics – Introduction
2. Definition as per Indian Regulation
3. Definition as per European Regulation
4. Classification of Cosmetics
5. Cosmetics as OTC drugs
6. Cosmetics as Quasi Drugs
7. Cosmeceuticals – Introduction
8. Mechanism of action of cosmeceutical
9. Classification of Cosmeceutical Products
10. Evolution of Cosmeceuticals from cosmetics
11. Reference

6. Cosmetics
Introduction
The word cosmetic was derived from the Greek word "kosm tikos" meaning having
the power, arrange, skill in decorating. Generally, cosmeceutical or cosmetic
substances refer to preparations that are meant for external use. They are applied
on external body structures like skin, hair, and nails. They are used to make
colouring, softening, cleansing, nourishing, protection, setting, mollification,
preservation, removal, and perming purposes.
Definition as per Indian Regulations
As per Section 3(aaa) of the Drugs and Cosmetics Act 1940 and Rules 1945,
Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed
on, or introduced into, or otherwise applied to, the human body or any part of body
for cleansing, beautifying, promoting attractiveness, or altering the appearance,
and includes any article intended for use as a component of cosmetic. Whether a
product is a cosmetic or a drug under the law, is determined by a product's
intended use. Different laws and regulations apply to each type of product. Firms
sometimes violate the law by marketing a cosmetic with a drug claim or by
marketing a drug as if it were a cosmetic, without adhering to requirements for
drugs. Cosmetics are regulated in India under the provisions of the Drugs and
Cosmetic Act 1940 and Rules 1945 vide Gazette notification G.S.R 426(E).
Definition as per European Union Regulation
The European Union Cosmetics Directive defines a cosmetic as "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.
"The European Union requires that cosmetic products placed on the EU market be

7. safe; that is, they "must not cause damage to human health when applied under
normal or reasonably foreseeable conditions of use." As in the U.S, manufacturers
are responsible for ensuring that cosmetic products comply with the law before
they are marketed. The manufacturer or importer of cosmetics is responsible for
demonstrating that the product is safe for its intended use.
Regulations are enforced at the national level, and each country in the EU has an
authoritative body that is responsible for upholding compliance. The 27 European
Union Member States have transposed the European Union Cosmetics Directive,
enacted in 1976, into national law. Each Member State has health authorities which
then regulate cosmetics within their respective national boundaries according to
the law.
Classification of Cosmetics
● Based on widely used body parts
Hair cosmetics
Face cosmetics
Eye make up
Nail cosmetics
Skin cosmetics
Lip decorators
● Based on physical form
Emulsion: Cold cream, vanishing cream
Powders: Face powder, talcum powder, tooth powder
Sticks: Lipsticks, deodorant sticks
Oils: Hair oils
Jellies: Hand jellies
Paste: Toothpaste, deodorant paste
Soap: Shampoo, Shaving soap
Solution: After shave solution
Aerosol: After shave spray
Cake: Rough compacts or face powder
Mucilage: Hand lotion, body lotion.
● Based on their function
Skin whitening and/or depigmenting cosmeceuticals

8. Moisturizing cosmeceuticals
Antiwrinkle cosmeceuticals
Sunscreen cosmeceuticals
Antiphotoaging cosmeceuticals
● Based on various products presently in the market
Antioxidants
Growth factors
Peptides
Metals
Antiinflammatories/botanicals
Polysaccharides
Pigmentlightening agents
● Based on colour cosmetics
Lip makeup products: Lipstick, lip gloss, lip balm, and lip liner
Eye makeup products: Mascara, eye liner, eye shadow, eye makeup remover.
Facial make-up products: Facial foundation, Blush, Concealer
Nail care products: Nail polish, Nail harderner, nail moisturizer, cuticle
remover, artificial nail, nail polish remover.
● Based on personal care products
Skin care products: Cleansers, moisturizers, products for special skin
concerns, Sunscreens, deodorants and antiperspirants
Hair care products: Shampoo, conditioners, styling products, permanent
waving and straightening products
Oral and dental care products: Toothpaste, mouthwash, and dental floss
Other products: Hair removal, baby care products, sunless tanners, feminine
hygiene products.

9. Fig. Classification of Cosmetics

10. Cosmetics as OTC Drugs
When producing a cream or lotion if you add an active ingredient or make a drug
claim and the intended use is to provide a physiological benefit beyond a purely
cosmetic effect, It is considered an OTC (over the counter) product. There are
products which are cosmetic products containing drug ingredients (cosmetic
drugs) and as such, fall into both definitions; cosmetics and drugs. There are
products that have multiple effects (cosmetic and pharmacological) and are
cosmetic product that contains active pharmaceutical ingredient that has a
pharmacological effect.
For example, an anti-dandruff shampoo is a cosmetic and pharmacological (drug)
product because it is being used to clean the hair as well as to treat dandruff.
Additional combinations of cosmetic and drug products are toothpastes to
prevent cavities, chap-sticks intended to heal, antiperspirant deodorants,
moisteners, suntan lotions claiming sun protection factors (SPF), medicated
shampoos and soaps for dry skin, dry scalp or dandruff, anti-aging facial creams.
Antidandruff agents (e.g. in Shampoos)
Dandruff occurs when skin cells on the scalp form too fast, meaning more skin
cells are shed and become clumps that can be seen by the naked eye. This may be
for a variety of reasons- product built up in the hair like shampoo, conditioner,
hair spray, gel, wax etc. that's not washed and rinsed properly. A major reason is
abnormally high levels of a fungus called Malassezia globosa, which is a type of
yeast and is always found on the scalp, even in those without dandruff. Inherent
factors like diet, stress levels, weather conditions, hair type (oily hair type is more
susceptible to dandruff) and even genetics play a role to some extent.
An antidandruff shampoo can be used to break and wash away any product build
up in your hair to leave it clean. The antidandruff agents include zinc pyrithione,
ketoconazole, selenium, sulphide, coal tar, salicylic acid, tea tree oil etc.
Most shampoos vary on the types as well as the strength of these ingredients;
hence the pH balance effect does not usually last for long. Most shampoos take
about 6-8 weeks of regular use to show results.

11. Fluorides (e.g. in Toothpastes)
Fluoride toothpastes make up more than 95% of all toothpaste sales. It is well
recognized that the decline in the prevalence of dental caries recorded in most
industrialized countries over the past 30 years can be attributed mainly to the
widespread use of toothpaste that contain fluoride. Investigations into the
effectiveness of adding fluoride to toothpaste have been carried out since 1945
and cover a wide range of active ingredients in various abrasive formulations.
Fluoride compounds and their combinations which have been tested for the
control of dental decay include sodium fluoride, stannous fluoride, sodium
monofluoro- phosphate and amine fluoride. The amount of fluoride contained in
fluoride toothpaste should be indicated on the toothpaste tube, although this
information may sometimes be hard to locate. It may appear after the label
"Active ingredient" or as a component under "Ingredients" on the toothpaste
tube. Whereas previously fluoride content was given as a percent of volume (%
w/v) or weight (% w/w), it is now accepted that the most efficient method of
informing people of the amount of fluoride in a toothpaste is to give the "parts
per million" fluoride (ppm F).
Most manufacturers now give fluoride content in ppm F. Under EU Directive
76/768/EEC, toothpastes are classified as cosmetic products. EU Directives
governing cosmetic products prohibit the marketing of cosmetic products
(including toothpastes) with over-the-counter levels of fluoride greater than 1,500
ppm F.
Sun protecting agents (e.g. in Sunscreens)
Sunscreen, also known as suncream or sunblock, is a lotion, spray, gel or other
topical product that absorbs or reflects some of the ultraviolet (UV) radiation and
thus helps to protect against sunburn. Skin-lightening products have sunscreen to
protect lightened skin because light skin is more susceptible to sun damage than
darker skin. Depending on the mode of action, sunscreens can be classified into
physical sunscreens (those that reflect the sunlight) or chemical sunscreens (those
that absorb the UV light). In addition to moisturizers and other inactive
ingredients, sunscreen formulations contain one or more of the following active
ingredients, which are either chemical or mineral in nature:
Organic compounds that absorb UV rays e.g. phenylbenzimidazole sulfonic acid,

12. Ensulizole, Eusolex 232, PBSA, Parsol HS, Eusolex OCR, 2-Cyano-3,3
dipheny! acid, 2-ethylhexylester, 2-Hydroxy-4-Methoxybenzophenone-5-
sulphonic acrylic acid, 3-Benzoyl-4-hydroxy-6-methoxybenzenesulphonic
acid, Benzophenone-4,Escalol 5777.
Inorganic particulates that reflect, scatter, and absorb UV light (such as titanium
dioxide, zinc oxide, or a combination of both).
Organic particulates that mostly absorb UV light like organic chemical
compounds, but contain multiple chromophores that reflect and scatter a fraction
of light like inorganic particulates. An example is Tinosorb M. The mode of action
is about 90% by absorption and 10% by scattering.
Antiperspirant Agents (e.g. in Deodorants)
Antiperspirants are personal hygiene products designed to control sweating and
body odour. Antiperspirants contain ingredients that control sweat and body
odour safely and effectively. They are readily available on the market as sprays
(aerosol), sticks, creams or roll-ons. When an antiperspirant is applied to the skin
surface, its antiperspirant ingredients usually aluminium salts dissolve in the
sweat or moisture on the skin surface of the armpit.
The dissolved substance forms a gel, which creates a small temporary 'plug' near
the top of the sweat gland, significantly reducing the amount of sweat that is
secreted to the skin surface. Bathing and washing will remove the antiperspirant
gel. Re-application of antiperspirants can be beneficial to help to reduce sweating
and keep fresh throughout the day. Antiperspirants reduce underarm sweating,
but they do not impact on the natural ability of the body to control its
temperature (thermoregulation).
Aluminium salts present in antiperspirants are natural antimicrobial agents, so
they also kill bacteria on your skin. High efficacy deodorants (without aluminium
salts) are available and rely on the use of specifically developed antimicrobial
agents, such as triclosan or polyhexamethylene biguanide. Alcohol is also effective
at killing bacteria, so deodorant and antiperspirant products that contain alcohol
(or ethanol) are able to reduce body odour by combating the odour-forming
bacteria.

13. Cosmetics drugs and OTC products require FDA pre-market approval via new drug
application (NDA) procedure or conform to a monograph as specified by FDA's
OTC drug review. These monographs define the analysis process of OTC drug
ingredients which will be identified for assuring safe and effective and not
misbranded cosmetic OTC product. You will need to assure OTC drug monograph
compliance for more than just your product labeling. The manufacturer will need
to provide testing of the active ingredients, stability data, good manufacturing
practice (GMP) compliance and process validation as well as FDA facility and
product registrations.
Products are not subject to the same regulation efforts, complexity, time,
registration and approval as drugs products. Moreover, cosmetics products
manufactured in general and cosmetics OTC products manufactured in particular,
will need to upgrade their manufacturing facility, quality assurance and
documentation, system machinery and in addition to adopt good manufacturing,
storage. Practices and validations in order to register the facility and enter the
cosmetics drugs combination on products.
As part of the cosmetic drug and OTC products manufacturer will
have to report their product's adverse effects to the FDA: The FD&C act (federal
food, drug and cosmetics act) restricted adulterated and /or misbranded
cosmetic products and strongly recommends to follow GMP standards, self
and/or external inspections and audits in addition to an effective quality system,
in order to minimize these kind of risks and to assure cosmetic products meet the
quality and their intended use consistently.
According to the FD&C act cosmetic products do not require FDA approval before
marketing, unless they contains color additives or may contain restricted
ingredients. Drugs however, require registration in the U.S including new drug
application submission to the FDA Cosmetic-drug combination products are
subjected to cosmetic and drug FDA regulation and should comply with OTC and
drug cosmetic labeling requirements.

14. The determination of whether a cosmetic is also a drug and therefore subject to
the additional statutory requirements that apply to drugs is based on the
distributor's intent or the intended use. The intended use of a product may be
established in several ways such as claims on product labeling or in advertising
/promotional materials or through the inclusion of ingredients that will cause the
product to be considered a drug because of a known therapeutic use.
The FDA has published several OTC categories monographs of nonprescription
drugs treatments such as acne, dandruff, seborrheic dermatitis, psoriasis
medications and sunscreens. Cosmetic products formulation registration is not
mandatory but for cosmetic OTC products manufacturers are obligated to register
their drug products (FDA) including drug active material being added to the
cosmetic product.
Cosmetic products manufacturers are solely responsible for both ingredients and
finished cosmetic products safety before marketing.
Ingredients safety can be tested on several animal models using the cosmetic
ingredients and monitoring irritation (skin, eye), allergic and toxicity following
ingredients exposure in order to prove the cosmetic product is safe for use.
Cosmetic drug and OTC products should be manufactured in facility that complies
with all current good manufacturing practices. The facility should be designed
according to GMP standards including proper construction material and facility
design.
OTC drug products monographs will include information to be labeled on the
product package in order to assure the product will not be misbranded.
Label will contain drug facts panel such as list of active ingredients, Drug
purposes, uses and applicable warnings, directions, inactive ingredients,
consumer service telephone number and other relevant information.

15. Merits of OTC Drugs
1. More satisfactory and less threats.
2. Less chances of misuse and abuse.
3. Customer can easily self-diagnose, self-treat and self-manage.
4. Appropriately labelled and no need of health professional.
Demerits of OTC Drugs
1. Less chances to know about the possible life style therapies.
2. Low compliance.
3. Misdiagnosed patients are prone to its threats, and will not be benefitted.
4. Tough to examine drugs effects.

16. Cosmetics as Quasi Drugs
Quasi drugs are one of the primary categories of beauty products in south Korea.
The other category of beauty products is cosmetics. There is a thin line between
drugs and cosmetics, which can be considered as quasi-drugs. Since their benefits
are not as suitable as drugs: South Korea’s health authority (HA) and the ministry
of food and drug safety (MFDS) has categorized them under skincare products like
acne for skin dullness.
Quasi drugs are generally classified into two types:
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 bandage, 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 as few protocols to
qualify.
Registration Process for Quasi Drugs
1. Submission – the data must be submitted to the HA for product
approval. Then for the safety and efficacy evaluation of the product will
be submitted to the cosmetics evaluation division (CED) and national
institute of food and drug safety evaluation (NIFDS). Lastly for the safety
and efficacy evaluation it will be handed over to medical products safety
division regional food and drug safety.
2. Review – after HA receives the safety and efficacy evaluations they will
review the specifications. Meanwhile they will also inspect the
manufacturing sites to assess the condition and quality of the

17. production.
3. Approval/Notification – HA will issue approval and notification both if it
qualifies in the Korean pharmacopoeia and other pharmaceutical
compendia recognized by the MFDS.
In Japancosmetics are regulated by the ministry of health, labour and welfare
(MHLW under the pharmaceutical affairs law (PAL). For legal purpoees beauty
products are divided into quasi-drugs and cosmetics. Japan accommodates
cosmeceuticals by calling quasi-drugs.
These are products that exert mild actions on the human body. The ingredients
included in quasi drug must be preapproved before marketed in Japan. All
products claiming to be cosmeceuticals are considered quasi drugs and require
preapproval before selling market. There regulations differ slightly but the
difference between cosmetics and quasi-drugs remains ambiguous. In practice,
this distinction is made based on differences in the effects assigned to each
product. The distinction is also influenced by a set of criteria, such as the nature
and the quantity of ingredients used, application method, dosage, and
And appearance of the product.

18. Fig. The Two Legal categories of personal care products in the US.
The pharmaceutical affairs law defines quasi-drugs an item for
the purpose of:
a. Preventing nausea and other discomfort
b. Preventing heat rash, soreness, etc.
c. Encouraging hair growth or removing hair
d. Exterminating and preventing mice, flies, mosquitoes, fleas, etc.
Among the quasi-drugs are deodorants, depilatories, hair growth treatments, hair
dyes, perm and straightening products, as well as medicated cosmetics, such as
whitening products, anti-aging products and oily skin or acne treatment products.
Besides, the item shall have mild effects on the human body, shall not be a utensil
or device and shall be designated by the MHLW based on these characteristics:
The approval for shall primary distribution is not always necessary for cosmetics;
however; this preapproval is mandatory in the case of quasi-drugs because they
contain active ingredients that need to be approved by the MHLW.

19. Pre approval is granted by the competent authorities if they judge that the
product answered all sanitary requirements. Items such as formula,
manufacturing method, application method and claimed effects are checked on
this occasion. Having an active ingredient approved by the MHLW allows the
product to display its effectiveness for a result that has yet to be recognized. This
allows companies to indicate that the product is medicated. This process takes
approximately six month for the MHLW to carry out the appropriate examination.
In Japan, sunscreens are classified as quasi-drugs, therefore, they require
approval of their formulations, ingredients, use levels and functionalities, in
addition to stability testing and a certificate showing no animal derived materials
were used. Product evaluations should be based on ISO 24442 in vivo testing and
labeling.
Also, an SPF of 50+, corresponding to PA+, is the maximum level allowed on the
label. The importation of quasi-drugs is much more expensive than cosmetics, the
whole price, including the various tests, notifications, approbations and so on,
could be as high as few million JPY (tens of thousands euros).
Regulations Cosmetics Quasi Drug
Approval for
manufacturing and sales.
Reported Required
Approval for
manufacturing and item.
Not Required Required
Approval for ingredients Not Required
(Excluding UV filters,
preservative, tar
colorants, etc.)
Required
(Excluding previously
approved ingredients)
Ingredients labelling Required for all
ingredients
Required specified
ingredients (Japan
voluntary standards,
required for all
ingredients).

20. Cosmeceuticals
Introduction
Cosmeceuticals refers to the combination of cosmetics and pharmaceuticals.
Cosmeceutical are cosmetic products with biologically active ingredients
purporting to have medical or a drug like benefits.
Cosmeceuticals are topically applied, but they contain ingredients that influence
the biological function of the skin. Cosmeceuticals improve appearance, but they
do so by delivering nutrients necessary for healthy skin. Cosmeceuticals typically
claim to improve skin tone, texture, radiance, while reducing wrinkling.
Cosmeceuticals are the fastest growing segment of the natural personal care
industry.
In most countries, a suitable regulatory category for these hybrid products does
not exist and therefore most complications in market development arise from a
lack of a clear definition and the consequent legal framework for cosmeceuticals.
Some cosmeceuticals are naturally-derived while others are synthetic; but all
contain functional ingredients with either therapeutic, disease-fighting, or healing
properties.
Cosmeceuticals means combination of cosmetics and pharmaceuticals.
Cosmeceuticals are cosmetic products with biologically active ingredients
purporting to have medical or drug-like benefits. Cosmeceuticals are used to
improve and nourish the skin appearance and known to treat different
dermatologic conditions. Like cosmetics, cosmeceuticals are also applied topically
having ingredients that influence the skin‘s biological function. Cosmeceuticals
are meant to improve appearance by delivering nutrients necessary for healthy
skin. Cosmeceuticals usually claim to reduce wrinkles and to improve tone,
texture and radiance of the skin. Cosmeceuticals products of herbal origin are
most liked among clients as they are mostly nontoxic and holding strong
antioxidant activity. Cosmeceutical product can be a drug, a cosmetic, or a
combination of both. But the term "cosmeceuticals" has no meaning under the
law".

21. Cosmeceuticals are not subject to be reviewed by the Food and Drug
Administration (FDA) and the term cosmeceuticals is not recognized by the
Federal Food Drug and Cosmetic Act. Although cosmetics and cosmeceuticals
both are being tested for their safety and tested to determine whether beneficial
ingredients actually live up to a manufacturer's claims is not compulsory. The
"cosmeceuticals" label applies only to products applied topically, such as creams,
lotions and ointments. Cosmetic labels do not have any division between active
ingredients and other ingredients that are essential, they are all listed together.
Mechanism of Action of Cosmeceuticals
Cosmeceuticals improve appearance but they do so by delivering nutrients
necessary for healthy skin. The cosmeceutical products act functionally. Evidence
to support the claims or use of cosmeceutical ingredients are often lacking in
literature. Many contain biologically active ingredients, and in general,
cosmeceuticals undergo tests to determine safety, but claims of efficacy are
largely unsubstantiated. Efforts have only recently been initiated to
address the issues surrounding quality control and to establish industry standards
and regulations. Demonstrating the skin effect of a cosmeceutical can be difficult;
there are no placebos because anything that is applied to the skin will have an
effect.
Fig. Basic Mechanisms of action of Cosmeceuticals

22. Classification of Cosmeceutical Products
1. Retinoids
Retinoids are premier evidence-based cosmeceuticals, as they function through
surface cell receptor interaction to produce a clinically defined effect. Other
retinoids such as pro-8 vitamins (niacinamide and panthenol) function differently
by physically enhancing barrier properties of stratum corneum. These are the
most prevalent cosmeceuticals in the market. They consist of natural and
synthetic derivatives of vitamin A that reduce hyperpigmentation and inhibit
enzymes from breaking down collagen. Many of their cosmeceutical claims are
based on data derived from studies on tretinoin and other classes of retinoid
drugs. Some key retinoids include retinoic acid (tretinoin), retinol, retinaldehyde.
Retinoic Acid (Tretinoin): There is extensive literature on the use of tretinoin,
which is considered to be one of the most potent compounds for treating the
signs of aging and/or photodamaged skin, including fine lines, hyperpigmented
spots, and wrinkles. However, side- effects such as burning and scaling have
limited its acceptance. In order to minimize these side-effects, various novel drug
delivery systems are being developed.

23. Retinol (Vitamin A): Retinol is oxidized into retinaldehyde and then into retinoic
acid, the biologically active form of vitamin A. In vivo studies showed that topical
retinol had only a modest retinoid-like biological activity compared with topical
retinaldehyde and retinoic acid. Two randomized, controlled trials reported
significant improvement in fine wrinkles after 12 and 24 weeks of treatment,
respectively.
Retinaldehyde: Retinaldehyde is viewed in a large part as an intermediate form
during the conversion of retinol to retinoic acid. Studies have shown that it does
have activity in human skin. Moreover, some studies have reported that this
retinoid can produce significant clinical improvement in the appearance offline
and deep wrinkles.
2. Sunscreens
Sunscreens are the single most important cosmeceutical, because they protect
skin against solar radiation, which is the most important damaging environmental
agent. As a result, they help to prevent the signs of aging. To be effective,
sunscreens should provide broad spectrum coverage that includes both UVA and
UVB blocking agents to inhibit photoaging and be part of a daily skin care
regimen. UVA and UVB radiation contribute to the disruption of the extracellular
matrix, a vital phenomenon related of photoaging. Broad-spectrum UVA and UVB
sunscreens are the cornerstone of photoaging therapy. Sunscreens contain active
ingredients that act as ultraviolet filters. Enzophenones (dioxybenzone,
oxybenzone, sulisobenzone) give protection in the UVB and UVA II range (320-340
nm). The recommended application is 2mg/cm, though this is rarely achieved in
real-life practice.
Green Tea Extract: Research has shown that green tea (Cammelia sinensis)
polyphenols are potent suppressors of carcinogenic activity from UV radiation and
can exert broad protection against other UV-mediated responses, such as
sunburn, immunosuppression, and photoaging.
Ferulic Acid: This compound, derived from plants, is considered to be a potent
antioxidant, and has been shown to provide photoprotection to skin.
Furthermore, when ferulic acid is combined with vitamins C and E the product has
been shown to provide substantial UV protection for human skin. Moreover,
because its mechanism of action is different from sunscreens, ferulic acid could
be expected to supplement the sun protection provided by sunscreens.

24. 3. Moisturizers
Moisturizers are most useful product for management of various skin conditions
(e.g., atopic dermatitis, psoriasis, pruritus, and aging skin). These products include
emollients, occlusives, and humectants. Majority of moisturizers enhance skin
barrier function. Moisturizers claim to make the skin smoother, softer, mare
radiant, less wrinkled and firmer. They improve the tactile properties of dry and
aging skin, restore the normal barrier function of the skin, and reduce the release
of inflammatory cytokines. Moisturizers based on materials such as petrolatum,
silicon, mineral oil and glycerin enhance skin barrier functions. Moisturizers
restore water content to the epidermis, and provide a soothing protective film.
4. Anti-oxidants
Topically applied antioxidants enhance the skin's natural antioxidant protection
system. They reduce free-radical damage by blocking the oxidative processes in
cells. These are used to protect skin from photo damage cancer and photoaging.
Antioxidants inhibit inflammation that causes collagen depletion. They protect
against photo damage and skin cancer. However, there is no completely
satisfactory agent available for humans. Explanations for this could include the
fact that:
• Reactive oxygen species (ROS) affect different pathways in different
situations and an antioxidant focused on one such pathway may be
ineffective in a redundant pathway.
• ROS pharmacokinetics in the target tissue may not relate to that of the
antioxidant.
• Bioavailability and target organ concentration of the antioxidant may be a
limiting issue.
Common antioxidants include alpha-lipoic acid (ALA), L-ascorbic acid (vitamin C),
niacinamide (vitamin B3), N-acetyl-glucosamine (NAG), á-tocopherol, and
ubiquinone (CoQ10) that are described below.
Alpha-Lipoic Acid (ALA): Alpha-lipoic acid has anti-inflammatory properties and
acts as an exfoliant. In a split face study, topical 5% ALA applied bid. for 12 weeks
reduced skin roughness, lentigines and fine wrinkles. This agent does not protect
against UV-induced erythema or reduce the number of sunburn cells.
L-Ascorbic Acid (Vitamin C): There is clinical data to support the use of topical
vitamin C to improve fine lines and reduce both pigmentation and inflammation,

25. and many cosmeceutical formulations contain this antioxidant. However, many of
these formulations are not effective on the skin because:
• The concentration of L-ascorbic acid is too low.
• Exposure of the product to air and light compromises the stability of the
product.
• The L-ascorbic acid molecule (in the form of an ester or a mixture of
isomers) cannot be absorbed or metabolized effectively by the skin.
In high enough concentrations (ie., at least 10%) of the non-esterified, optimal
isomer, this antioxidant does inhibit UV damage. It is important to note that
stabilizing ascorbic acid presents many formulary challenges. However, a
formulation that has an acid pH of approximately 3, may optimize vitamin C
absorption. Newer formulations of stabilized ascorbic acid derivatives may prove
to be more efficacious.
Niacinamide Vitamin B3): Niacinamide is a potent antioxidant that is generally
well tolerated. It improves the lipid barrier component of the epidermis, thus
reducing trans-epidermal water loss, and acts as an inhibitor of melanosome
transfer, resulting in reduced hyperpigmentation. Studies have revealed
significant reduction in fine lines and wrinkles, hyperpigmented spots, red
blotchiness, and skin sallowness, as well as improved skin elasticity.
N-Acetyl-Glucosamine (NAG): NAG is a more stable form of glucosamine, and
may prevent new signs of photodamage from occurring, and fade existing
imperfections by interrupting the chemical signals that promote melanin
production. A placebo-controlled study comparing 3.5% NAG With the
combination of 3.5% NAG plus 3.5% niacinamide on hyperpigmented spots
showed a superior reduction in pigmentation in the combination treatment group
versus both the placebo and NAG only groups. When combined, they produce
synergistic effects.
Alpha-Tocopherol (Vitamin E): When taken orally, a-tocopherol protects
membrane lipids from peroxidation. It has been shown to reduce sunburn cells
after UV exposure, neutralize free radicals, and act as a humectant. Its activity can
be renewed by combining it with a vitamin C preparation. As a component in
topical formulations, it, like unmodified L-ascorbic acid, has shown some limited
efficacy. However, when a stable formulation delivers a high concentration of the
non-esterified, optimal isomer of this antioxidant, vitamin E does inhibit the acute
UV damage of erythema, sunburn, and tanning, as well as chronic UV photoaging

26. and skin cancer.
Because vitamin C regenerates oxidized vitamin E, the combination in a
cosmeceutical formulation is synergistic particularly with regard to UV protection.
Ublquinone (CoQ10): Ubiquinone is a naturally occurring, fat-soluble antioxidant
and there is good in vitro evidence that it can suppress fibroblast production of
UVA-induced collagenase, thereby reducing collagen breakdown. It has been
shown to be effective against UVA mediated oxidative stress in human
keratinocytes. Ubiquinone was also able to significantly suppress the expression
of collagenase in human dermal fibroblasts following UVA irradiation. Another
study showed that ubiquinone can strongly inhibit oxidative stress in the skin
induced by UVB. It is an effective antioxidant protecting the dermal matrix from
both intrinsic and extrinsic aging
Grape Seed Extract: It is a potent antioxidant and has been shown to speed
wound contraction and closure. Topical application of grape seed extract has also
been shown to enhance the sun protection factor in humans.
5. Hydroxy-acids
These include a-hydroxy-acids (AHAS; glycolic acid, lactic acid) and B-hydroxyacids
(BHAs; salicylic acid). Hydroxy-acids are used worldwide and most probably for
centuries as active dermatological drug and cosmetic ingredients. The exact
mechanism of action of hydroxy-acids remains unknown and is largely
controversial. Some experts claim that AHAs increase the synthesis of
glycosaminoglycans which improve the quality of elastic fibers, and increase
density of collagen; whereas BHAs have dermolytic properties and help in various
xerotic and ichthyotic disorders. AHAs are also referred to as fruit acids; and are a
common ingredient of cosmeceutical products. Examples include citric acid, malic
acid, glycolic acids, pyruvic acid, lactic acid, tartaric acid. AHAs improve skin
texture and reduce the signs of aging by promoting cell shedding in the outer
layers of the epidermis and by restoring hydration. The mechanism of action is
not completely understood. One hypothesis suggests that AHAs reduce the
calcium ion concentration in the epidermis and, through chelation, remove the
ions from the cell adhesions, which are thereby disrupted, resulting in
desquamation. This is enhanced by cleavage of the endogenous stratum corneum
chymotryptic enzyme on the cadherins, which are otherwise protected from
proteolysis by conjugation with calcium ions. The resulting reduction of the

27. calcium ion levels tends to promote cell growth and slow cell differentiation, thus
giving rise to younger looking skin.
6. Topical Proteins and Peptides
Cosmeceutical peptides have the potential to improve the appearance of aging
skin. Topical peptides are regarded as cellular messengers that are formed from
amino acids and are designed to mimic peptide fragments with endogenous
biologic activity. These pentapeptides (e.g. KTTKS) are comprised of a
subfragment of type I collagen propeptide, and play a role in signalling fibroblasts
to produce collagen in the skin, which can improve the appearance of wrinkles.
One variation, the palmitoyl pentapeptide known as Pal-KKTKS Matrixy, Sederma)
was tested in a controlled, double-blind, left-right randomized, split face study of
93 women between 35 and 55 years of age who had Fitzpatrick 1-M type skin.
Pal-KTTKS concentration was 3 ppm; both groups were treated twice daily for 12
weeks. Improvements in wrinkle appearance and length were observed.
There are various types of cosmeceutical peptides such as signal peptides, carrier
peptides, and neurotransmitter inhibiting peptides. Overall cosmeceutical
peptides trigger wound-healing mechanism that activates fibroblasts in response
to fragmented chains of elastin and collagen. Peptides increase collagen
production to improve skin appearance resulting in smoother skin.
7. Depigmentation agents
Skin-lightening agents added to product formulations have become increasingly
popular. Common depigmenting ingredients include hydroquinone, ascorbic acid
(vitamin C), kojic acid, and licorice extract (glabridin).
Hydroquinone: Hydroquinone has been the agent of choice for skin lightening.
However, there are concerns over exogenous Ochronosis and permanent
depigmentation, as well as possible carcinogenicity, and it has been banned as an
over-the-counter depigmenting agent in Europe, Australia and Japan. The US FDA
has proposed concentrations between, 1.5% and 2% in skin lighteners. A recent
report suggested that this concern has been based mainly on studies with animal
models utilizing long-term exposure at high dosages. Routine topical application
may pose no greater risk than that from levels present in common foods.
Hydroquinone is effective and widely used for treatment of melasma, post-
inflammatory hyperpigmentation. It acts by inhibiting conversion of tyrosine to
melanin.

28. Ascorbic acid (Vitamin C): Ascorbic acid is a naturally ocurring antioxidant found
in citrus fruits and leafy green vegetables. It is hydrophilic, so skin penetration ís
low.
Kojic acid: Kojic acid is a less commonly used bleaching agent. When combined
with dipalmitate, there is improved skin penetration and greater stability, but
there is little research to support its efficacy.
Licorice Extract (Glabridin): Several studies on melasma have shown good
efficacy with only mild irritation that disappeared with discontinuation.
8. Growth factors
Epidermal growth factor (EGF) stimulates epidermal growth and is used in the
treatment of burns and excision wounds, where it accelerates re-epithelization.
Transforming growth factor (TGF) stimulates normal skin growth and cellular
growth and repair. TGF exerts positive regulatory effects on the accumulation of
the body’s extracellular matrix proteins. TGF is also a mediator of fibrosis (repair
tissue formation) and angiogenesis (development of new blood cells) and it
promotes the healing of wounds.
Evolution of Cosmeceuticals from Cosmetics
1. The health-giving property of cosmetics was first identified by the
Egyptians. The cosmetics were first used by Egyptians in 4000 B.C whose
records are being available.
2. The health-providing property of cosmetics was first discovered by the
Egyptian in 4000 B.C.
3. Up to the beginning of 19th century, there was no clear separation
between cosmetics and pharmaceuticals, the separation occurred when the
first modern pharmaceutical industry was developed.
Till early 19" century, there was no definite difference between cosmetics
and pharmaceuticals, the separation happened when the first modern the
pharmaceutical industry was established.

29. 4. In 1980's there was a rapid expansion of the cosmeceuticals due to hydroxy
acids (natural fruit acids) used as exfoliants against winkles.
In 1980's, a rapid expansion of the cosmeceuticals occurred due to hydroxyl
(acids natural fruit acids) used as exfoliants against wrinkles.
5. In 1961 the term cosmeceuticals was coined by the Raymond Reed,
founding member of the United States Society of Cosmetic Chemists.
In 1961 the word cosmeceuticals was created by the Raymond Reed,
founding member of the United States of Cosmetic Chemists.
6. Albert Klingman in 1917 developed a formula to improve the appearance
of UV damaged and wrinkled skin, using retinoic acid thereby reactivated
interest of the people in cosmeceuticals. World-renowned dermatologist.
In 1971, Albert Klingman, world's renown dermatologist, created a formula
to enhance the appearance of UV harmed and wrinkled skin, utilizing
retinoic acid thereby regenerated the intrigue of the masses in
cosmeceuticals.
7. Dr. Klingman made a long-lasting contribution to the world of skincare by
discovering that topical retinoic acid (or tretinoin) can be used for both an
acne and wrinkle treatment.
Dr. Klingman made a long-standing contribution to the world of skincare by
establishing that topical retinoic acid (or tretinoin) can be utilized for both
an acne and wrinkle treatment.
8. Dr. Klingman may be described as the father of cosmeceuticals, a term he
popularized; but cosmeceuticals first appeared in the world market in 1996.
9. The several cosmetic jars have been unearthed by the Archaeologists
whose hieroglyphics say "good for sight" and "stops bleeding".

30. The Archaeologist whose hieroglyphics reads "good for sight" and "stop
bleeding" has unearthed several cosmetics jars.
10.A medical papyrus "Ebers," which was written in 1600 BC, makes frequent
reference to a number of cosmeceuticals-type products.
"Ebers" a medical papyrus written in 1600 BC, makes recurring reference
to a number of cosmeceutical-type items.
11.The favourite was the one prepared using honey and milk that claimed to
help cure skin' diseases, while differénť product mentioned in the Ebers.
claiming to "expel wrinkles from the face", were made from frankincense.
balantine oil, rush oil and wax in equal proportions.
The best was the one prepared from milk and honey that declared to cure
skin discases, while the product introduced in the Ebers, declaring to "expel
wrinkles from the face", were prepared from frankincense, balantine oil,
rush oil, wax in similar proportion.
12.A dark powder knows as Kohl was being applied around the eyes in a
almond shape with a stick. Kohl was made of different colours of copper
ore, lead, ochre, ash, burnt almonds and oxidised copper.
Kohl was being put around the eyes in drop shape with a stick. Kohl was a
dark powder made up of distinct colours of copper ore, lead, ochre, ash,
burnt almonds and oxidized copper.
13.Red clay mixed with water was the choice of make-up, for the cheeks and
lips. Henna was used to paint the finger-nails yellow or orange. Henna was
used to colour the finger-nails yellow or orange. Red clay mixed with water
was used for cheeks and lips as make-up.

31. 14.Egg whites, gum Arabic, beeswax and gelatine were used to create nail
colour in ancient China.
In ancient China, nail colour was prepared by egg whites, gum Arabic,
beeswax and gelatine.
15.As time moved on cultures were fused and the Greeks began to move into
cosmetics history and accept the use of Egyptian cosmetics. They did it just
simply to look good and not for spiritual purposes.
With passing time cultures were mixed, the Greek showed interest in
cosmetics history and acquired the use of Egyptian cosmetics. They did it
just to look good.
16.Centuries later, as the Romans moved in they started the use of cosmetic
formulas for other purposes, such aş creating aphrodisiacs. They started to
use blood mixed sheep fat for nail polish and instead of just using the
traditional body oils created by Egyptians, they took baths in mud and
crocodile excrement.
After Centuries, Romans started using cosmetics formula for purpose like
creating aphrodisiacs. They used blood mixed with sheep fat for nail paint
and in place of using the body oils formulated by Egyptians, they took bath
in mud and crocodiles remain.

32. References
1. Singh S.P., & Nigam V., Cosmetic science, Thakur publication Pvt. Ltd.,
Lucknow, first Edition 2021, Page No.-15-21
2. Shelikh A.A., Deshman S. V., Biyani K. R., Usman M.R.M., A text book of
cosmetic science, Pee Vee Books, first edition 2021, Page No.-1-8.
3. Fredric S. Brandt, M.D., Alex Cazzaniga, Michael Hann, Cosmeceuticals:
Current Trends and Market Analysis. Semin Cutan Med Surg, 2011;
30:141-143.
4. Pathak k. & Vaidyo A., A text book of Cosmetic science concepts &
principles, Nirali prakashan Advancement of knowledge, Pune, first
edition - 2018, Page No.-1.1-2.15.
5. Pitanguy I. Future directions in plastic surgery. 3rd European congress in
aesthetic dermatology and surgery & European congress of anti-aging
medicine; 2007 Oct 12-14; Paris, France.