OUR LADY OF FATIMA UNIVERSITY

College of Pharmacy
PCOS311 - Cosmetic Product Development

WEEK 8
TOPIC 3: Skin Care Products
(Part 2)
 UNIT OUTCOMES

At the end of this unit, the

students are expected to:
Demonstrate understanding on
the safety and evaluation of skin
care products

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 CHECKLIST

Read unit outcomes and unit

objectives
Read course guide prior to class
attendance
Proactively participate in
discussions
Watch videos related to the topic
Participate in discussion board
(Canvas)
Answer and submit course unit
tasks 3
Required Readings

Baki, G., & Alexander, K. S. (2015).

Introduction to Cosmetic
Formulation and Technology. New
Jersey, USA: John Wiley & Sons.
Iwata, H., & Shimada, K. (2013).
Formulas, Ingredients and
production of Cosmetics. Tokyo,
Japan: Springer Japan.
Tadros, T. F. (2016). Formulations: In
Cosmetic and Personal Care. Berlin:
de Gruyter Publisher.

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SAFETY AND EVALUATION:
SKIN CARE PRODUCTS

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 SAFETY AND EVALUATION: SKIN CARE PRODUCTS

One of the skin’s primary

physiological functions is
to act as the body’s first
line of defense against
exogenous agents.
However, the skin should
not be viewed as a
flawless physicochemical
barrier.
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SAFETY AND EVALUATION: SKIN CARE PRODUCTS

Many low–molecular weight compounds

are capable of penetrating this barrier.
When toxic agents (such as irritants or
allergens in cosmetic products)
permeate it, the resulting adverse
effects may cause considerable
discomfort to the consumer.
Even minor disturbances of the skin
surface can produce discomfort,
especially in the facial area which has an
extensive network of sensory nerves.

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TYPES OF COSMETICS ALLERGIC REACTION

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 TYPES OF COSMETICS ALLERGIC REACTION

1. CONTACT DERMATITIS
 This is a nonspecific term used to
describe any inflammatory skin
disease resulting from contact
with an irritant or allergenic
substance.
 Whatever the causative agent, the
clinical features are similar:
itching, redness, and skin lesions.

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 TYPES OF CONTACT DERMATITIS

A. IRRITANT CONTACT DERMATITIS

(IRRITATION)
It is a term given to a complex group of localized
inflammatory reactions that follow
nonimmunological damage to the skin.
The inflammation may be the result of an acute
toxic (usually chemical) insult to the skin, or of
repeated and cumulative damage from weaker
irritants (chemical or physical).
There is no definite laboratory test for ICD—
diagnosis is by clinical morphology, of course, and
appropriate negative patch-test results.

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Categories of ICD:
Acute Irritant Contact Dermatitis
 Acute ICD is the result of a single overwhelming exposure to a strong irritant or
a series of brief physical or chemical contacts, leading to acute inflammation of
the skin.
Cumulative Irritant Contact Dermatitis
 Cumulative irritant contact dermatitis or chronic ICD develops as a result of a
series of repeated and damaging insults to the skin. The insults may be
chemical or physical.
Delayed Acute Irritant Contact Dermatitis
 Some chemicals produce acute irritation in a delayed manner so that the signs
and symptoms of acute irritant dermatitis appear 12 to 24 hours or more after
the original insult.

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 TYPES OF CONTACT DERMATITIS

B. ALLERGIC CONTACT DERMATITIS

ACD occurs when a substance comes into
contact with skin that has undergone an
acquired specific alteration in its reactivity as a
result of prior exposure of the skin to the
substance eliciting the dermatitis.
The skin response of ACD is delayed,
immunologically mediated (Type IV), and
consists of varying degrees of erythema,
edema, papules, and papulovesicles.
Patch testing is the gold standard.

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TYPES OF CONTACT DERMATITIS

C. PHOTOIRRITANT CONTACT
DERMATITIS
It is a chemically induced
nonimmunological skin irritation
requiring light. This reaction will occur in
all individuals exposed to the chemical–
light combination.
Bergapten, a component of bergamot
oil, is a potent photoirritant that causes
berloque dermatitis.

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TYPES OF CONTACT DERMATITIS

D. PHOTOALLERGIC CONTACT
DERMATITIS
It is an immunological response to a
substance that requires the presence of light.
The substance in the skin absorbs photons
and is converted to a stable or unstable
photoproduct, which binds to skin proteins to
form an antigen, which then elicits a delayed
hypersensitivity response.
Examples of photoallergens present in
cosmetics are musk ambrette and 6-
methylcoumarin, which are present in
fragrances.
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 TYPES OF COSMETICS ALLERGIC REACTION

2. CONTACT URTICARIA SYNDROME

It represents a heterogeneous group of
inflammatory reactions that appear,
usually within a few minutes to an hour,
after contact with the eliciting substance.
Clinically, erythematous wheal-and-flare
reactions are seen, and sensations of
burning, stinging, or itching are
experienced.
Diagnosis may be achieved by a variety of
skin tests—the open test is the simplest of
these and is the ‘‘first-line’’ test.
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TYPES OF CONTACT URTICARIA SYNDROME

I. Nonimmunological Contact II. Immunological Contact Urticaria

Urticaria
It is the most common class of
CUS. The reaction usually
remains localized.
Examples of cosmetic
substances known to produce
NICU are preservatives (e.g.,
benzoic acid and sorbic acid)
and fragrances (e.g., cinnamic
aldehyde)
These are immediate (Type I)
allergic reactions in people who
have previously been sensitized
to the causative agent.
ICU is IgE mediated and is more
common in atopic individuals.
Food substances are common
causes of ICU.

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 TYPES OF COSMETICS ALLERGIC REACTION

3. ACNEGENICITY
 This refers to the capacity of some
agents to cause acne or aggravate
existing acne lesions.
 This term may be subdivided to
include comedogenicity and
pustulogenicity.

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 TYPES OF ACNEGENICITY

I. Comedogenicity II. Pustulogenicity

This is the capability of an agent
to cause hyperkeratinous
impactions in the sebaceous
follicle, or the formation of
microcomedones, usually in a
relatively short period of time.
This refers to the capability of an
agent to cause inflammatory
papules and pustules, usually in a
relatively short period of time.

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 SAFETY AND EVALUATION: SKIN CARE PRODUCTS

Factors Contributing to Contact Allergic Reactions to a Cosmetic

Product
Frequency of Use
Composition
Concentration of Ingredients
Purity of Ingredients
Common Use of Cosmetic Ingredients in Pharmaceuticals
Cross-Sensitivity
Penetration-Enhancing Substances
Application Site
Condition of the Skin
Contact Time 19
 SAFETY AND EVALUATION: SKIN CARE PRODUCTS

Common Components that cause Cosmetic Allergic Reaction:

Fragrance Ingredients
Preservatives
Antioxidants
‘‘Active’’ or Category-Specific Ingredients
Excipients and Emulsifiers
Coloring Agents

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PRODUCT SAFETY TESTING

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 PRODUCT SAFETY TESTING

International regulatory agencies require that skin care products

available on the market do not cause damage to human health when
applied under normal and reasonably foreseeable conditions of use.
Adequate information must be readily available to demonstrate product
safety and this information should be keep on file with all other studies
supporting performance product claims.

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 PRODUCT SAFETY TESTING

Such safety information could be based on the individual toxicity of

ingredients but testing the final product is important and pertinent
particularly in the following cases:
 A new ingredient known to cause slight
eye or skin irritation is present
 Significant modifications of the
formulation have been made;
 The vehicle used in the formulation
results in significantly greater skin
penetration
 Interaction between ingredients is likely
to result in the formation of a new,
potentially toxic or irritant substance
 There is a specific safety claim
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 TYPES OF SAFETY ASSESSMENT

1. PATCH TEST
 a test for determining allergic sensitivity
that is made by applying to the unbroken
skin small pads soaked with the allergen
to be tested
 The 48-hour patch test allows the
assessment of the primary irritation
potential of a topical product.
 The test is conducted on a panel of at
least 25 subjects. The patches used can
be occlusive or semi-occlusive
depending on the nature of the product.

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 TYPES OF SAFETY ASSESSMENT

2. Human Repeat Insult Patch

Test (HRIPT)
 a test for determining the irritation
and/or sensitization potential of a test
material(s), in support of sensitive skin
claims, after repeated application under
occlusive or semi-occlusive patches to
the skin of human subjects.
 The HRIPT consists of 2 phases, and
sometimes 3.

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 TYPES OF SAFETY ASSESSMENT

3. NON-COMEDOGENIC TEST
 a test to evaluate the skin condition
before and after one month of product
usage. The evaluator counts the number
of comedons and blackheads on the
forehead, cheeks and chin.
 Alternatively, a non-comedogenic claim
can be assessed via a microscopic
examination of the skin after application
of patches containing the product.

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 TYPES OF SAFETY ASSESSMENT

4. NON-ACNEGENIC TEST
 a test to evaluate skin condition
before and after one month of
product usage. The evaluator
counts the number of acne
lesions (papules and pustules) on
the forehead, cheeks and chin.

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 TYPES OF SAFETY ASSESSMENT

5. PERIOCULAR TOLERANCE TEST

 a test that allows to assess the irritation potential of a topical product applied
on the eye contour area.
 The study is conducted under the supervision of an ophthalmologist. The
condition of the eye and around the eye area is examined before and after a
given period of product usage.

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 Related videos and links

(See How Skincare is Made ft. Glow

Recipe | Sephora)
https://www.youtube.com/watch?v=yt
2jFoYC8Jc
(Skincare Manufacturing | Creams,
Serums & Lotion Manufacturing)
https://www.youtube.com/watch?v=q
6ZHsguhEIY
(How to Make Cosmetic Creams)
https://www.youtube.com/watch?v=Y
Z60WWBVtmc
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 References

Barel A., Paye M. and Maibach H.

(2009). Handbook of Cosmetic
Science and Technology, 3rd ed. New
York: Informa Healthcare USA, Inc.
Butler, K. (2000). Poucher’s Perfumes,
Cosmetics, and Soaps 10th ed. Great
Briatain; Kluwer Academic Publishers.

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 Thanks!

ANY QUESTIONS?

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