COSMETICS

INTRODUCTION
Prepared by: Jean Kathleen A. Gran, RPh
 COSMETIC
A cosmetic is any article intended to be applied to the human body for
cleansing, beautifying, promoting attractiveness, or altering
appearance WITHOUT affecting the body's structure or functions.

FDA DEFINITION (USA): "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.“

KEY POINT: Cosmetics do NOT affect body structure or function!

 INTRODUCTION
• The word cosmetic derives from the Greek Kosm tikos meaning 'having the
power, arrange, skilled in decorating',
• DRUGS AND COSMETICS ACT
- Cosmetics are defined as articles intended to be rubbed, poured,
sprinkled or sprayed on, introduced into or otherwise applied to the human
body or any part thereof cleansing, beautifying, promoting attractiveness or
altering the appearance
- Cosmetic is a preparation or substance intended to be placed in
contact with the external parts of the human body or the teeth and the
buccal mucosa with the aim of cleaning, perfuming, improving the
appearance, and keeping them in good condition.
 COSMETIC VS. DRUG - THE
CRITICAL DISTINCTION

COSMETIC DRUG
• Sunscreen (SPF claims)
• Moisturizing lotion
• Anti-acne cream
• Lipstick
• Shampoo
• Dandruff shampoo
• Perfume • Whitening products (therapeutic
claims)
• Hair dye
• AntiperspirantAnti-aging (therapeutic
• Deodorant (non-antiperspirant) claims)
Beautify, cleanse, enhance
appearance Treat, prevent, cure disease/condition
 COSMETIC SCIENCE
• Cosmetic science is the study of the effects that raw materials and mixtures
can have on parts of the human body like hair, skin, lips, and nails. In
recent years, cosmetic scientists and their colleagues have been working
to advance the field in a positive direction.
• The multidisciplinary field that encompasses the study of formulation,
development, testing, manufacturing, and safety assessment of cosmetic
products.
 KEY COSMETIC TERMINOLOGIES
• 1. FORMULATIONThe process of combining ingredients in specific
proportions and order to create a stable, safe, and effective cosmetic
product.

• 2. EXCIPIENT An inactive substance that serves as the vehicle or medium for

active ingredients (e.g., water, oils, emulsifiers).

• 3. ACTIVE INGREDIENTA component that provides the intended cosmetic

benefit (e.g., retinol for anti-aging, hyaluronic acid for hydration).

• 4. PRESERVATIVESubstances added to prevent microbial contamination

and extend shelf life (e.g., parabens, phenoxyethanol).
• 5. EMULSION: A mixture of two immiscible liquids (oil and water) stabilized
by an emulsifier.O/W (Oil-in-Water): Oil droplets in water - like lotionsW/O
(Water-in-Oil): Water droplets in oil - like cold creams

• 6. STABILITY TESTING: Evaluating how a product's quality changes over time

under various environmental conditions (temperature, light, humidity).

• 7. Ph: Measure of acidity/alkalinity. Skin's natural pH is ~4.5-5.5 (slightly

acidic). Cosmetics should be compatible with skin pH.

• 8. BATCH/LOT NUMBER: Unique identifier for each production batch,

essential for traceability and quality control.
 KEY COSMETIC TERMINOLOGIES
• 9. INCI (International Nomenclature of Cosmetic Ingredients) Standardized
system for naming cosmetic ingredients, required on product labels
worldwide.
Example: Water = "Aqua", Vitamin E = "Tocopherol"
• 10. SAFETY ASSESSMENT Evaluation of potential risks associated with
cosmetic ingredients and finished products through toxicological studies.

• 11. SHELF LIFE The period during which a product remains safe and
effective under specified storage conditions (typically 2-3 years for
cosmetics).
• 12. PAO (Period After Opening) How long a product remains safe after
opening, indicated by jar symbol with number (e.g., 12M = 12 months).
 HERBAL COSMETICS

- when cosmetics are prepared using plant products having cosmetic

actions, they are known as HERBAL COSMETICS
HISTORY OF COSMETICS
 HISTORY OF COSMETICS

PRE HISTORIC TIMES -- 3000 BC up to present

 Examples of Cosmetics

• Skin-care creams,
• powders,
• lotions,
• lipsticks,
• nail polishes,
• eye and face makeup,
• deodorants,
• baby products,
• hair colorants and
• sprays etc.
 USES
1. They are used as cleansing, moisturizing, and beautifying agent.
2. They help in enhancing the attractiveness of the body.
3. They help alter the body’s appearance without affecting its functions.
4. Sunscreen products help in protecting the body from UV rays and treat
sunburns.
5. Acne, wrinkles, dark circles under the eyes, and other skin imperfections are
treated or repaired by treatment products.
6. Cosmetics help in treating skin infections.
 EMULSIFICATION
• Emulsifying is the process step of mixing two or more normally unmixable or
unblendable liquid phases in an overall product system or formulation. The process
of emulsification is widely used in industrial applications involving chemical
processing, liquid pharmaceutical products and food & beverage processing.
• Water in oil or oil in water
• Types of emulsifiers commonly used in skin care products include sodium lauryl
sulphate (SLS), benzalkonium chloride, behentrimonium methosulphate, cetearyl
alcohol, stearic acid, glyceryl stearate and ceteareth
• Familiar foods illustrate examples: milk is an oil in water emulsion; margarine is a
water in oil emulsion; and ice cream is an oil and air in water emulsion with solid
ice particles as well. Other food emulsions include mayonnaise, salad dressings,
and sauces such as Béarnaise and Hollandaise
• Egg yolk & Soy bean- contains an emulsifying agent called “lecithin”
• In cosmetics, an emulsifier includes any ingredient that helps keep unlike
ingredients (such as oil and water) from separating in an emulsion.
Examples of cosmetics ingredients that function as emulsifiers include
polysorbates, laureth-4, and potassium cetyl sulfate. Emulsifiers are widely
used throughout the cosmetics industry and are the unsung heroes of
many cosmetics formulas that blend and help to keep unlike ingredients
together. There is also research showing they can help enhance the
absorption of skincare ingredients and may be useful for prolonged topical
delivery.
 MIXING

• Mixing is a process that involves intermingling products of different

chemistries to obtain a definite material. As mentioned by Nienow &
Edwards the mixing operation involves both physical and chemical
changes, thus it is the most important operation in pharmaceutical,
chemical, food industries, etc.
• Mixing is required for blending, solid-suspension, slurries, heat transfer,
dissolving, gas dispersion, emulsification, flocculation, leaching,
saponification, fermentation, etc. But the key area of our interest is
emulsification, blending and slurry mixing.
• Cosmetic creams and other similar products are used for various purposes
like moisturizing, cleaning and beautification of body. The raw materials
include acids, alkalis, antioxidants, emollients, sunscreen, vitamins, colors,
wax, butter, clay, etc. These are mixed uniformly by the process of
emulsification. Since the materials used are immiscible it is necessary to
keep this material in constant motion (for Eg. In the case of mixture of oil
and water). Aggregates and single drops will settle at different rates as per
Stoke’s Law, thus, it’s very important to study the rate of flocculation for
such processes. The viscosity of such creams is around 250,000 centipoise
or more, thus it is necessary to keep such a highly viscous liquid in
continuous motion for mixing it thoroughly and uniformly.
 COMPACTION

What is compaction and its importance?

• Compaction is a process of increasing soil density and removing air, usually
by mechanical means.
• one method of producing granulates that uses pressure to minimize the
space between individual particles. Both processes are essential to the
production of pharmaceutical products such as pills, capsules, and tablets.
MOULDING
 CATEGORIES OF COSMETICS
Cosmetics are broadly categorized into four types:
• 1. Skin Cosmetics
• 2. Hair Cosmetics
• 3. Nail Cosmetics
• 4. Cosmetics for hygiene purposes
• the most common animal "test subjects" for cosmetics include mice, rats,
rabbits, and guinea pigs. The testing is conducted to determine the toxicity
of a product, and to observe any skin or eye irritation. Some of them wind
up severely injured by this testing methodology, and sometimes, the
reaction is so severe that it can result in death.
• Testing methods vary based on the animal. According to Cruelty-Free
International,
• The FDA still insists upon rigorous testing before a cosmetic product can get
premarket approval. This does not specifically require the use of animal
testing, but the FDA does still require that companies “do whatever is
necessary to ensure the safety of their products,"
 : PART II - COSMETIC GOOD
MANUFACTURING PRACTICE (GMP)
• WHAT IS COSMETIC GMP? A system of guidelines and practices that ensures
cosmetic products are consistently produced and controlled according to
quality standards appropriate to their intended use.
• PURPOSE OF GMP: ✓ Ensure product quality ✓ Minimize contamination risks
✓ Protect consumer safety ✓ Maintain batch consistency
BASED ON STANDARDS:
• ISO 22716 (International Standard)
• ASEAN GMP
• FDA Guidelines (USA)
• Local regulations (PH-FDA)
 KEY ELEMENTS OF COSMETIC GMP
• 8 ELEMENTS:
PERSONNEL - Qualified, trained staff
PREMISES - Proper facilities
EQUIPMENT - Maintained tools
RAW MATERIALS - Quality ingredients
PRODUCTION CONTROL - Written procedures
QUALITY CONTROL - Testing & release
DOCUMENTATION - Complete records
COMPLAINTS & RECALL - Issue handling
 GMP ELEMENT 1 - PERSONNEL
✓ Adequate Number of Qualified Staff
Sufficient personnel with appropriate education and experience
✓ Proper Training & Competency Assessment
Initial training, ongoing education, skill evaluation
✓ Personal Hygiene Requirements
Clean clothing, handwashing, no jewelry in production areas
✓ Health Monitoring
Medical examinations, illness reporting, exclusion when sick
✓ Defined Responsibilities
Clear job descriptions, organizational charts, authority levels
 GMP ELEMENTS 2 & 3 - PREMISES
AND EQUIPMENT

PREMISES ( FACILITIES) EQUIPMENT

• Designed to prevent contamination • Appropriate for intended use
• Adequate space for all operations. • Regular maintenance &
calibration
• Proper ventilation and lighting.
• Cleaning & sanitization SOPs
• Separate areas for different activities
• Documentation of equipment use
• Easy to clean and maintain
• Non-reactive materials (stainless
• Appropriate workflow steel preferred)
• Proper storage when not in use
 GMP ELEMENT 4 - RAW MATERIALS
& PACKAGING
✓ Approved Suppliers Only: Qualified suppliers who meet quality standards
✓ Incoming Inspection & Testing: Verify identity, quality, and specifications
before acceptance
✓ Proper Storage Conditions: Temperature control, light protection, humidity
control, segregation
✓ FIFO System (First-In-First-Out)Use older materials before newer ones to
prevent expiration
✓ Specifications & Certificates of Analysis: Documented quality standards for
all materials
 GMP ELEMENT 5 - PRODUCTION &
PROCESS CONTROL
✓ Written Manufacturing Procedures: Step-by-step instructions for each
product - no guesswork!
✓ Batch Production Records: Document every step: ingredients, amounts,
times, operators
✓ In-Process Controls & Testing: Monitor critical parameters (pH, viscosity,
appearance)
✓ Prevention of Cross-Contamination: Clean equipment between batches,
separate areas, dedicated tools
✓ Defined Processing Times & Conditions: Specific mixing times,
temperatures, cooling periods
 GMP ELEMENT 6 - QUALITY
CONTROL (QC)
QUALITY CONTROL - THE GATEKEEPER:
✓ 3-Stage Testing Program
1. Raw materials testing
2. In-process testing
3. Finished product testing
✓ Specifications & Acceptance Criteria: Clear standards for pass/fail
decisions
✓ Stability Testing Programs: Ensure products remain stable over shelf life
✓ Microbiological Testing: Test for bacteria, yeast, mold, pathogens
✓ Release or Rejection Authority: QC decides if batches can be sold -
independent from production
 GMP ELEMENTS 7 & 8 - DOCUMENTATION AND
COMPLAINTS
DOCUMENTATION: "If it's not RETENTION: Usually 1 year after
documented, it didn't happen" product expiry

• Master formulas • System for recording complaints

• Manufacturing procedures • Investigation procedures
• (SOPs)Batch production records • Recall procedures and plans
• Specifications for • Traceability systems
materials/products • Corrective and preventive actions
• Testing results and release records
• Deviation and corrective action
reports
 COSMETIC PRODUCT
NOTIFICATION
WHAT IS COSMETIC PRODUCT NOTIFICATION? The regulatory requirement to
inform the relevant authority (e.g., FDA) about cosmetic products before they
are placed on the market.
WHY IS NOTIFICATION REQUIRED?
• Enables regulatory oversight and market surveillance
• Ensures products meet safety standards
• Protects public health
• Provides traceability in case of safety issues
• Required by law in most countries
 WHO MUST FILE NOTIFICATION?

• THREE TYPES OF ENTITIES:

MANUFACTURERS Companies that produce cosmetics locally
IMPORTERS Companies bringing cosmetics from other countries
DISTRIBUTORS Companies marketing products under their name

THE RESPONSIBLE PERSON: The entity legally responsible for ensuring the
product complies with regulations. They are accountable for safety, quality,
and proper labeling.
 INFORMATION REQUIRED FOR
NOTIFICATION
• 6 CATEGORIES OF REQUIRED INFORMATION:
Product Information
• Product name, category, intended use, target population
Company Information
• Name, address, contact details of responsible person
Complete Formula/Ingredient List
• All ingredients in descending order using INCI names
Product Label
• Copy of actual label with all required information
Safety Data
• Safety assessment, stability tests, microbiological tests
Manufacturing Details
• Manufacturing site address, GMP certification
 NOTIFICATION PROCESS &
TIMELINE
TYPICAL NOTIFICATION PROCESS:
STEP 1: Prepare Documentation Gather all required information and documents
STEP 2: Submit Application File through online portal or physical submission
STEP 3: Review by Authority Regulatory body evaluates completeness and safety
STEP 4: Approval/Certificate Issuance Notification certificate or approval granted
TIMELINE: Varies by country
• Philippines: Typically 30-90 days
• Can be longer if deficiencies need correction
 PROHIBITED & RESTRICTED
INGREDIENTS
RESTRICTED INGREDIENTS Ingredients
PROHIBITED INGREDIENTS Ingredients that allowed only under specific conditions
are completely banned in cosmetics: or concentration limits:

• Heavy metals (mercury, lead • Preservatives (e.g., parabens ≤

compounds) 0.4% for single ester)
• Certain carcinogenic substances • UV filters (specific concentrations)
• Prohibited preservatives • Colorants (must be from
• Banned colorants approved lists)
• Certain fragrances (must be
labeled if allergenic)
 LABELING REQUIREMENTS

• REQUIRED LABEL INFORMATION:

✓ Product Name ✓ Net Contents (weight/volume) ✓ Ingredient List (INCI
names, descending order) ✓ Manufacturer/Responsible Person Info ✓
Batch/Lot Number ✓ Expiry Date or PAO Symbol ✓ Directions for Use ✓
Warnings/Precautions (if applicable) ✓ Country of Origin ✓ Notification
Number (if applicable)
• ALL INFORMATION MUST BE:
• Legible and indelible
• In the official language(s)
• Visible to consumers at point of sale
 SUMMARY - KEY TAKEAWAYS

• PART I: DEFINITIONS & TERMINOLOGIES ✓ Cosmetics vs. Drugs - determined

by intended use and claims ✓ Cosmetic Science - multidisciplinary field
(chemistry, biology, regulation) ✓ 12 Essential terminologies mastered
• PART II: COSMETIC GMP ✓ Ensures consistent quality and safety ✓ 8 Key
Elements: Personnel, Premises, Equipment, Raw Materials, Production
Control, QC, Documentation, Complaints/Recall ✓ Based on ISO 22716,
ASEAN GMP, and local regulations
• PART III: PRODUCT NOTIFICATION ✓ Required before marketing products ✓
Submitted by manufacturers, importers, distributors ✓ Comprehensive
documentation needed ✓ Timeline: 30-90 days (Philippines)