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Benedictine University Cosmetic Chemistry Course Topics

Date Module Focus Speaker Company 11-Sep 18-Sep 25-Sep 2-Oct 9-Oct 16-Oct 23-Oct 30-Oct Introduction to Cosmetics - Trends, Size of Industry, Products, Chemical Classes, Raw Materials Used, Formulation Types Scott Wenzel Tom Schoenberg Perry Romanowski Perry Romanowski Craig Bonda TBD TBD Anna Gripp Kimberly-Clark

Surfactants - Types of Surfactants, Surfactant Chemistry, Formulation of Surfactants


Emulsions - Types of Emulsions, Emulsion Theory, Formulation of Emulsions Formulation Module - What is Formulating, How to Formulate Various Types of Products in the Industry OTC Sunscreen Development and Chemistry Polymer Science - Polymer Chemistry, Use of Polymers in Hair and Skin Care Delivery of Actives and Molecules in Cosmetics The Use of Active Ingredients in Personal Care Cosmetic Product Manufacturing - How to Take a Formulation from Lab Scale to Manufacturing Scale, What are the Challenges of the Contract Manufacturing Business Claim Substantiation for Cosmetic and OTC Products for Skin and Hair - Types of Claims, Types of Testing, How to Design Studies

Schoenberg Consulting, Inc.


Alberto Culver Alberto Culver Hallstar BASF or ISP BASF DSM

6-Nov

Gene Frank

Raani Corporation

13-Nov

Barb Dvoracek

Kimberly-Clark

Who is Scott Wenzel?


Educational and Work History
May 1994 - Graduated from UW-LaCrosse with a B.S. in Biology/Chemistry

Sept 1994 Tsumura International hires Scott as a Jr. Formulation Chemist


Dec 1998 Northwest Cosmetic Laboratories hires Scott as R&D Mgr

April 2002 NuSkin hires Scott as Sr. Research Scientist


Dec 2004 Kimberly-Clark hires Scott as Sr. Research Scientist Aug 2007 Currently Technical Leader for R&D Formulation Team
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Who is Scott Wenzel?


SCC Background Member of SCC since 1994 Sept 1997 Treasurer of Twin Cities Chapter of SCC

Jan 2003 Founder of the Intermountain West Chapter of SCC


Jan 2003 First Chair of the Intermountain West Chapter of SCC Aug 2003 Coordinated first annual Intermountain West Chapter SCC Golf Outing

Jan 2004 Serve a 2nd term as Chair of the Intermountain Chapter of SCC
Sept 2006 Chair-Elect of Midwest Chapter of SCC Sept 2007 Chair of Midwest Chapter of SCC

Society of Cosmetic Chemists


Dedicated to the advancement of cosmetic science, the Society strives to increase and disseminate scientific information through meetings and publications. Promotes research in cosmetic science and industry and improves the qualifications of cosmetic scientists. Founded in 1945, it now has over 4,000 members There are now 18 chapters with membership from 35 to 1100 members For further information, visit www.scconline.org

Midwest Chapter of Society of Cosmetic Chemists


Was the first chapter formed in 1948 Today has almost 400 members Chapter holds 7 educational meetings/year as well as 1-2 social events/year in the Chicago area Chapter also hosts a vendor supplier day, which will occur in March 2008 Publishes a newsletter called SCCoop For more information, visit www.midwestscc.org

Cosmetic Overview

Overview of Presentation
How large is the cosmetic industry? What are the trends?

What types of products are in the market?


What ingredients are used? What types of formulations are utilized?

Cosmetic Industry
Size and Growth

Globally $253 Billion Revenue in 2005 (Euromonitor);


3.7% Growth through 2010 $300 Billion Highly Fragmented Thousands of finished good companies from garage scale to multibillion dollar corporations Thousands of raw material suppliers Low barriers to entry (not capital intensive) Trend increasing with direct to consumer channels

Marketing Intensive

Overview of Cosmetics and Toiletries Worldwide Category Size


CAGR to 2011 projected at 3.0%

Overview of Cosmetics and Toiletries Breakdown by Sub-Category


1.1% 23% 2.4% 1.7% 7.8% 4.5% 18.6% Baby Care Bath and Show er Products Deodorants Hair Care Color Cosmetics Men's Grooming Products Oral Hygiene Fragrances 10.9 % 9.4% 7.8% 12.8% Skin Care Depilatories Sun Care

Hair Care and Skin Care are biggest subcategories.


Copyright and database Euromonitor International 2007 10

Overview of Cosmetics and Toiletries Channel


2006 World Cosmetics and toiletries Supermarkets/hypermarkets Independent food stores Convenience stores Pharmacies/drugstores Discounters Department stores Specialists Direct sales Outdoor markets Others

25.5 3.1 2.4 18 7.6 12.6 12.7 12.9 1.4 3.6


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Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries Sales by Region


2001 Cosmetics and World Asia Pacific Australasia Eastern Europe Latin America Africa and Middle East North America Western Europe 2006 196,375.60 269,909.10 48,926.70 64,971.30 2,388.50 4,138.10 9,233.50 19,301.90 22,991.30 36,342.90 14,244.80 11,827.90 48,762.00 55,903.50 49,828.70 77,423.50

Copyright and database Euromonitor International 2007

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Overview of Cosmetics and Toiletries Key Trends and Influences


Demographics: ->Falling birth rates ->Aging Populations ->Age Compression ->Wellness

Economic: -> Non-Essentials

-> Polarization of Wealth

Copyright and database Euromonitor International 2007 13

Overview of Cosmetics and Toiletries Key Trends and Influences


Social Trends: ->Urbanization -> Changing Lifestyles -> Nutrition -> Celebrity Culture -> Environmental/Ethical

Political Activity: -> Globalization -> Regulation

Copyright and database Euromonitor International 2007 14

Overview of Cosmetics and Toiletries Key Trends and Influences

Technology: ->Efficacy, multi-functionality -> New Media

Company Activity: -> Consolidation -> Education -> Mega-Branding -> Cross-Industry Innovation
15 Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries Baby Care

Earths Best Baby Body Care

Gerbers Products With Skin Nutrients

Baby Spa with Oatmeal

16 Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries Bath and Shower


Vitamins Moisturizers Minerals Antibacterial

17 Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries Deodorants

Body Sprays

Sticks and Roll-On

Unisex Products Split to Gender


18 Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries Hair Care

19 Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries Color Cosmetics

20 Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries Skin Care

21 Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries Depilatories

22 Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries Sun Care

23 Copyright and database Euromonitor International 2007

Cosmetic Industry Jobs


Types of Companies
Contract Manufacturers Multi-level Companies Direct Sales Companies Raw Material Vendors Fragrance Suppliers Distributors

Science Related Jobs in these Companies


Formulation Chemist

Analytical Chemist
Quality Control Specialist Microbiologist and Life Scientists Perfumers Technical Sales

Science Related Intellectual Property and Law

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Classes of Formulations and Raw Material Overview

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Overview
What is a cosmetic and drug?

What is formulating?
Classes/functions of raw materials

Definitions Examples of some raw materials in each class


Product types in the industry

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What is a Cosmetic
The Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "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" [FD&C Act, sec. 201(i)].

Said another way


A substance or preparation intended for placement in contact with any external part of the human body, including: the mucous membranes of the oral cavity and the teeth; with a view to: altering the odours of the body; or changing its appearance; or cleansing it; or maintaining it in good condition; or perfuming it; or protecting it.

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Are All Cosmetics Created Equally???

The FD&C Act defines drugs by their intended use, as "(A) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease..and (B) articles (other than food) intended to affect the structure or any function of the body of man or other animals"

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Formulation Defined
The act, process, or result of formulating or reducing to a formula. Webster's Revised Unabridged Dictionary (1913)
A.K.A Advanced Baking or Bucket Chemistry

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Formulation Defined
Formulating is a: ComplexIterative.Combination of Art and Science

Performance

Aesthetics

Stability Scale Up Preservative Efficacy

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What Ingredients Do We Choose?


2006 International Cosmetic Ingredient Dictionary and Handbook features: 13,000 INCI names recognized in the United States, the European Union (EU), and many other countries as the labeling names that MUST be used on cosmetic and personal care product packages. These INCI names are crossreferenced to 59,000 trade names associated with more than 3,000 suppliers from 95 countries. 15 Sections containing all the critical information needed to identify INCI labelling names, CAS and EINECS registry numbers, Empirical formulas, CIR Index, OTC Index, EU Index, sources to find additional information about specific ingredients, and much more.
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General Classes of Raw Materials


Surfactants
Cleansing agents Emulsifiers

Skin Conditioning Agents


Humectants Emollients Occlusive Agents/Film Formers

Rheology Modifiers (Viscosity Increasing Agents)


Aqueous Nonaqueous

Preservatives Chelating Agents Active Ingredients

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Surfactants
Surfactants Cleansing agents

Used for skin/hair cleansing purposes. In this function, surfactants wet body surfaces, emulsify or solubilize oils, and suspend soil.
It is characteristic, and expected by most consumers that these should contribute foam/lather to cleansing products. Examples: Sodium Lauryl Sulfate (SLS) Ammonium Laureth Sulfate (ALES)

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Surfactants
What is a surfactant? A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface. How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance. Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the Head & Tail approach. The elongated hydrophobic end is the tail, while the hydrophilic end is the head

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Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface (2) As the concentration is increased the surfactants aggregate in the solution and form micelles, reducing surface tension

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC)
Surface Tension (N/m) Concentration

Increasing surfactant concentration does not result in in a further decrease of surface tension.
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Surfactants
Surfactants Emulsifying Agents Are employed in cosmetics to prepare emulsions. Their efficacy depends on their ability to: Reduce surface tension Form complex films on the surface of emulsified droplets Create a repulsive barrier on emulsified droplets to prevent their coalescence. Examples: Ceteareth-20 PPG-2 Isoceteth-20 Acetate Glyceryl Stearate SE

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General Classification of Emulsifiers


CTFA website lists 1893 materials of emulsifiers! Emulsifier

Non-ionic

Ionic

Anionic
GMS-SE TEA-Stearate Sodium Cetearyl Sulfate

Cationic

Amphotheric

Lecithin Cetylpyridinium (Phospholipids) Chloride Distearyldimonium Chloride


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Non-Ionic Emulsifiers
Fatty-alcohol ethoxylates dominate but also includes PEG, Glyceryl, Sucrose and Polyglyceryl esters, ether and, in many instances, silicone based compounds Typical alkyl chain for alcohol ethoxylates distributed between C12-18. Broad compatibility Inexpensive Generally organized by hydrophilic/hydrophobic character (HLB) Best stability & effectiveness is achieved through combinations of emulsifiers E.G. Arlacel 165 is a commercial blend of 50% Glyceryl Stearate (HLB 12) and 50% PEG-100 Stearate (HLB 18.8) allow for a broad range or materials to be emulsified. Achieves: smallest droplet size, highest stability, lowest amount of surfactant

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Typical Non-Ionic Emulsifiers


Glyceryl Stearate PEG-100 Stearate Stearyl Alcohol Cetyl Alcohol Laureth-23 Steareth Alcohol Cetyl/PEG/PPG 10 Dimethicone Stearic Acid Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Many are more effective as rheology modifiers
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Anionic
Cetyl Phosphate

Sodium Dihydroxycetyl Phosphate


Sodium Lauroyl Lactylate C10-C30 Alkyl/Acrylate Crosspolymer (Pemulen TR-2)

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Cationic
Consumer Products Using Cationic Emulsifiers

Distearyldimonium chloride

Dry, powdery, smooth skin feel is able to mask high lipophilic content
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Oil and Water Dont Mix

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Unless you are a formulator!

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Normal Oil/Water Interaction


Oil and water alone cannot form an emulsion. The phases will separate once energy is removed from the system (kinetically unstable).

Something needs to be added to stabilize the emulsion

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Love?

Oil + Water 4 Ever

Well, maybe a little

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Surfactants - Emulsifiers
Surfactant = Surface Active Agent
A molecule with a polar head group and a non-polar tail Polar Non-polar

For emulsions, these are usually nonionic surfactants although there are others

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Surfactants - Emulsifiers
Surfactants can have more non-polar character than polar character and vice-versa. These represent different HLB values.
Less polar (low HLB) More Polar (High HLB) Specific oils need specific surfactant polar/non-polar character to be effectively emulsified.
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Examples of matching HLB values to application needs


mixing unlike oils together use surfactants with HLBs of 1 to 3 making water-in-oil emulsions use surfactants with HLBs of 4 to 6 wetting powders into oils use surfactants with HLBs of 7 to 9 making self emulsifying oils use surfactants with HLBs of 7 to 10 making oil-in-water emulsions use surfactant blends with HLBs of 8 to16 making detergent solutions use surfactants with HLBs of 13 to 15 for solubilizing oils ( micro-emulsifying ) into water use surfactant blends with HLBs of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection. Uniqema. Presentation to the Midwest Chapter of the Society of Cosmetic Chemists.48 09 March 2004.

Surfactants - Emulsifiers
When added to oil and water, a surfactant will arrange itself such that its non-polar tail is within the oil and its polar heads are exposed to the water. Spherical arrangement of surfactant is known as a micelle. Polar heads Oil Droplet

Non-polar tails
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Emulsion!
An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other. Continuous phase and dispersed phase

The surfactant maintains the small droplet size of the oil, keeps the droplets from aggregating (steric hinderance) and the surfactant/oil complex is soluble in the water.

This is known as an oil in water emulsion (O/W)

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Skin Moisturization

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Moisturizers Are Everywhere!

Lotions and Creams

Body Washes

Hand Sanitizers

Hand Soaps

Lip Balms

Sunscreens
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The importance of skin moisture

Too Wet
Skin maceration Loss of barrier function Reduced rate of barrier repair Corneocyte swelling Wrinkling

Just Right

Too Dry
Skin flaking Loss of skin barrier Loss of skin elasticity Skin cracks/fissures Painful and/or pruritic skin Skin roughness
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Factors that effect skin moisture


Skins ability to control water diffusion (Skin Barrier Function)

Skins ability to retain water (Natural Moisturizing Factors)

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How Do Moisturizers Work?

Enhancing barrier function This is generally done with skin conditioning agents

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Skin Conditioning Agents


Emollient

Help maintain the soft, smooth, and pliable appearance of skin.


They function by their ability to remain on the skin surface or in stratum corneum Act as lubricants, to reduce flaking, and to improve the skins appearance.

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Skin Conditioning Agents


Emollients can be:

Hydrocarbons Mineral Oil


Natural Oils Jojoba Oil Esters Isopropyl Palmitate, Myristyl Myristate

Triglycerides Caprylic/Capric Triglyceride


Silicones Cyclomethicone

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Skin Conditioning Agents


Occlusive Retard the evaporation of water from the skin surface and, therefore, increase the water content of the skin. Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin. i.e. Hydrocortisone Creams Examples: Petrolatum Beeswax Paraffin Wax Dimethicone Shea Butter

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Skin Barrier: The Brick and Mortar Model


The stratum corneum is composed of corneocytes (bricks) embedded within a lipid matrix (mortar)

= Corneocyte (cell remnant) = Lipids


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Skin lipids help maintain normal barrier


H2O H2O
H2O H2O

H2O

Vs.
Normal Skin w/ Normal Barrier Dry Skin w/ Damaged Barrier

Inflammation

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Barrier Function Repair


H2O
H2O

H2O
Apply Lipids
H2O

Irritant
H2O

Dry Skin w/ Damaged Barrier

Lipids Repair Barrier Damage


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Formulation Considerations
Most are water insoluble, so must be delivered either in the oil phase of an emulsion system or in an anhydrous system. Too much of a barrier material can result in a formulation that feels greasy, waxy, or heavy. Fatty materials can go rancid over time; preservatives should be used to delay or prevent this.

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How Do Moisturizers Work?

Enhancing water absorption and retention

This is generally done with humectants

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Skin Conditioning Agents


Humectant

Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin.
Examples: Glycerin, Propylene Glycol

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Humectants in Formulations
Stratum corneum (dried and cracked)

Relief !!!
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Raw Materials that Enhance Moisture Retention


Glycerin

Alpha-hydroxy acids
Urea Pyrrolidone Carboxylic Acid (PCA)

Glycols (propylene, butylene)


Amino acids

Glycerin is by far the most commonly seen

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Formulation Considerations
Most humectants are water-soluble, and can easily be incorporated in water-based formulations. Use in anhydrous formulations is limited.

Many formulations (especially washes, soaps, or hand sanitizers) that state with moisturizers on the label contain glycerin or another humectant.

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Skin Benefits Attributable to Moisturizers


Decrease dry, flaky appearance

Reduce the incidence of fine lines and fissures


Increase skin elasticity and suppleness Provide relief from itching or pain

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Moisturizers Result in More Elasticity

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Shai, A. et al. Eds. Handbook of Cosmetic Skin Care (2001)

Moisturizing Formulas on the Market


Water, Glycerin, Stearyl Alcohol, Mineral Oil, Glyceryl Stearate, Myristyl Myristate, PEG 100 Stearate, C12 - 15 Alkyl Benzoate, Dimethicone, Cetyl Alcohol, Stearic Acid, Phenoxyethanol, Fragrance, Carbomer, Methylparaben, Potassium Hydroxide, Ethylparaben, Disodium EDTA, Propylparaben, Butylparaben, Xanthan gum, Microcrystalline Wax, BHT, Butylene Glycol, Aloe Barbadensis (Leaf Extract), Calendula Officinalis (Calendula) Flower Extract, Camellia Oleifera Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Retinyl Palmitate, Tocopheryl acetate
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Moisturizing Formulations
Active Ingredients: Dimethicone
Inactive Ingredients: Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Oat Flour (Avena Sativa), Benzyl Alcohol, Sodium Chloride

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Additional Ingredients

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Film Formers
Materials which, upon drying, produce a continuous film on skin, hair, or nails Uniform films can enhance the efficacy of an active such as a sunscreen, skin protectant or moisturizer. Can be used to improve the wash off or removal of an active ingredient from the skin surface. Examples: PVP PVA Ethylene Vinyl Acetate Copolymer

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Viscosity Increasing Agents


Aqueous
Are used to thicken the aqueous portions of cosmetic products. Ability to thicken is related to the water solubility or hydrophilic nature. Examples of aqueous thickeners:

Salts Sodium Chloride, Ammonium Chloride


Cellulose Type HEC, HPMC, CMC Gums Guar, Xanthan, Acacia Modified Starch Potato, Tapioca

Polymers - Pemulen TR-1, Carbomer

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Polysaccharide Thickening Mechanism


Formation of Colloidal Network High yield value

Excellent pH and electrolyte tolerance


Effective across a broad pH range Excellent temperature and electrolyte stability Good solubility in hot and cold water Rheology may be too stiff for some applications Synergy with other rheology modifiers (e.g. clays)
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Clays
Magnesium Aluminum Silicate (e.g. VEEGUM) Smectite clay platelets
Hydrates in water

Forms necessary colloidal structure; house of cards


Positively charged edges of platelets interact with negatively charged faces to build structure

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Clay Platelets
Negatively charged platelet faces and positively charged edges

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Forms Structure
When hydrated, clay assembles a 3D structure

Traps solids, oils, and gasses

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Viscosity Increasing Agents-Anhydrous


Nonaqueous Used to thicken the lipid portions of cosmetic products. Ability to thicken is the result of their water insolubility and compatability with lipids. Examples of aqueous thickeners: Waxes Beeswax, Microcrystalline Wax Alcohols Cetyl, Stearyl Butters Shea Butter Hydrogenated Oils

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Preservatives
Ingredients which prevent or retard microbial growth and thus protect products from spoilage. Use is required to prevent rancidity, appearance/odor changes to the product caused by microorganisms Protects activity/functionality of the product Protects from inadvertent contamination by consumer during use or production. The functionality of many classes is determined by the pH, conditions of manufacturing and order of addition. To prevent microbial growth in a product Examples: DMDM Hydantoin Parabens Phenoxyethanol Quaterniary Amines

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Types of preservation
Radiation Heat or cold

Packaging
Chemical and Natural Preservatives
Water activity reducers

Antioxidants
Chelators pH adjusters

Antimicrobials
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Brief History of Preservatives


3000BC Salt, honey and oils used to preserve mummies in Egypt. ???? BC Salt used to preserve meats around the world. 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer. 1875 Benzoic acids preservative properties are discovered. Gum benzoin had been discovered in 1556 by Nostradamus 1876 Refrigerators invented cold known to help preserve. 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them Pasteurization. 1924 Parabens introduced into cosmetics for preservation. 1939 Sorbic acids preservative properties are discovered. 1945 After WWII, new chemistries develop new needs for preservatives. Synthetic preservatives flourish. 1970s Regulations are tightened on cosmetics around the world, affecting preservative choices.

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Microbial Paradise
Cosmetics contain food numerous food sources for microbes: water, proteins, trace metals, carbon, amino acids. pH of products can enhance microbial growth Most bacteria flourish in pHs between 6.5-7.5, but actual range of growth is 4.5-9.0 Yeasts abound around 4.0-6.5, but can be seen as low as 1.5 and up to 9.6 Molds enjoy a pH between 4.5 and 6.8, but can found between 1.2 (A. niger) and 11. High water activity is preferred Most bacteria need activity above 0.90, S. aureus can go to 0.84 Most yeasts prefer above 0.87, osmophilic yeasts can survive down to 0.60 Most molds are prefer water activity above 0.60

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Things to Consider
What are we concerned with as formulators? Gram negative bacteria Gram positive bacteria Yeast/mold Best preservative system is one that is broad a broad spectrum blend Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens Optiphen Plus (ISP) is a blend of phenoxyethanol, caprylyl glycol, and sorbic acid Use preservative boosting techniques Chelating agents such as EDTA pH modification with acids/bases Water activity reducers (glycols,

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CTFAs 28-Day Micro Challenge


Inoculum consists of Escherichia coli (G-), Enterobacter cloacae (G-), Pseudomonas aeruginosa (G-), Burkholderia cepacia (G-), Staphylococcus aureus (G+), Candida albicans (Y), and Aspergillus niger (M) All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFU/mL Colonies are counted at 1, 7, 14, 21 and 28 days The preservative is effective if there is: Bacteria: at least a 99.9% reduction within 7 days following each challenge and no increase for the duration of test period, and; Yeast and Mold: at least a 90% reduction within 7 days following each challenge and no increase for the duration of the test period.

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Chelating Agents (Sequestrants)


Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products. At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients. Chelation of ions, such as iron or copper, helps retard oxidative deterioration of finished products.

Chelating agents are used to help boost preservative efficacy in cosmetic formulations.
Examples: Tetrasodium EDTA Disodium EDTA Gluconic Acid

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Active Ingredients
Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used. Incorporated to alter the structure and function of the skin. Within cosmetics, over-the-counter products (rash creams, sunscreens) are regulated by the FDA under an appropriate monograph. Are all products which change the structure or function of skin regulated by the FDA: No!!! Is there consistent agreement as to what it means to change the function & structure of skin: No!!! Claim language is the fine line to distinguish cosmetic from a drug:

Cosmetics: smoothes, soothes, moisturizes, plumps, etc.

Drug: cures, treats, prevents, etc.

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Skin Protectants
OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli, and may help provide relief to such surfaces. Examples:
Allantoin Dimethicone Petrolatum

Zinc Oxide

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Other Examples of Active Ingredients


OTC Regulated Cosmetics:
Sunscreens Rash Creams Anti-Puritic (Itch Anti-Dandruff Anti-Perspirants External Analgesics (Pain Reduction) Hand Sanitizers Anti-wrinkle Anti-cellulite Stretch marks Skin Lighteners (US)

Non-Regulated Products with Actives

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Fragrance, Colorants, Aesthetic Enhancers, and Label Ingredients

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Overview
Why are they used in formulations

Classes/functions of raw materials


Definitions Examples of some raw materials in each class

Product types in the industry

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Why are they used in formulations?


Additives can be:
Functional
Deliver an end benefit. If used in low quantities, functional ingredients enhance appeal

Enhance appeal
Enhance the five senses of the consumer (sight, smell, touch, taste, hearing)

Create a story and also be functional


Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

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General Classes of Raw Materials


Fragrance Fragrance blends Essential Oils Extracts or Waters Flavor Colorants Dyes Pigments Natural colorants Marketing Ingredients Extracts Moisturizers Vitamins Antioxidants
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General Classes of Raw Materials


Aesthetic Enhancers Visual Beads Glitter Swirls Opacifiers or pealizing agents Sensory Warming Cooling Tactile Powdery finish Exfolliants

Natural Synthetic
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Aroma Compounds
Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors Types of aroma compounds Fragrance A mixture of fragrant essential oils, aroma compounds, solvents, and fixatives Can be extremely complex and contain a top note (perceive immediately upon application), middle note (heart of the fragrance), and base note (perceived after dry down) Essential Oils Hydrophobic portion of a steam distillate Large interest due to the popularity of aromatherapy Examples are Lavender Oil, Peppermint Oil Hydrosols Aqueous phase of a steam distillate and often referred to as essential water, floral water, or herbal distillate Example are Rose Water, Orange Water
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Flavorant
A substance added to impart a pleasant taste to the final formulations
Product Examples
Toothpaste

Mouthwash
Lip Balm Adult novelty products

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Colorants
Materials which impart a visual color to a finished product Types of colorants Dyes Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially Examples are FD&C Yellow No. 5 and D&C Orange No. 4 Pigments Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light. Examples are FD&C Yellow No. 5 Aluminum Lake and D&C Orange No. 4 Aluminum lake Natural Examples are Walnut Extract and Beet Extract
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Marketing Ingredients
Materials which do not add to the end benefit of the product, but help to create the product story and reason to believe Generally these are added in very small amounts Examples: Extracts
Helianthus Annuus (Sunflower) Extract

Moisturizers
Jojoba oil, Aloe

Vitamins
Vitamin A, Vitamin E, Vitamin C

Antioxidants
Green Tea Extract, Vitamin C

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Aesthetic Enhancers - Visual


Materials and or effects that are added to formulations to entice the consumer buy by creating a wow for the eyes. Examples: Beads Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins, oils) Glitter or iridescent pigments Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine. Swirls Can be layers of two separate products or an internal swirl (alternate benefits) Opacifiers or pearlizing agents Suspended fatty acids, powders, or other to create a white or luminescent appearance to the product

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Aesthetic Enhancers - Sensory


Materials added to formulations to stimulate the senses or elicit a response from touch Examples: Warming Agents Generally warm due to heat of hydration
Examples would be glycols, magnesium chloride, calcium chloride

Cooling Agents
Due to volatile evaporation or from a neurosensory response
Examples would be ethanol, menthol, camphor

Tactile Agents
Examples would be powders or silicones to elicit a smooth, powdery finish on the skin

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Exfoliants
Materials added to formulations aimed at improving skin's appearance by removing dead skin cells from the surface of the skin.
Examples: Physical Synthetic
Polyethylene beads

Natural
Walnut shells Rice bran

Chemical
Alpha Hydroxy Acids (AHAs) such as Glycolic Acid, Lactic Acid, Citric Acid Beta Hydroxy Acids (BHAs) such as Salicylic Acid Polyhydroxy Acids (PHAs) such as Gluconolactone, Lactobionic Acid

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Industry Examples

Warming Facial Cleanser (Biore)

Suspended Antibacterial Beads (B&BW)

Enriched with Aloe & Vitamin E (J&J)

Suspended Exfoliant Apricot Shells (St. Ives)

Pigments for color transfer

Lavender Aromatherapy

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Formulation Systems
Solutions Oil Based Solutions/Anhydrous Water Based Surfactant Solutions Emulsions Suspensions Powders

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Solutions
Homogeneous mixture of two or more substances.
Examples:
Astringents (Hydro-alcoholic) Anti-septic/microbial Hand Gels

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Anhydrous Formulations
Systems which do not contain water Contains mostly hydrophobic/lipophilic ingredients.
Examples: Ointments, Lip balm/sticks, Vaseline

Advantages: Lipophilic material has direct contact with the skin, best film formation, and film is not water dispersible (water resistant/proof), ease of preservation.

Disadvantage: Poor aesthetics and more costly.

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Foaming surfactant systems


Dispersion of hydrophilic surfactants in water. (Micellular Surfactant Solutions) Examples:
Shampoos Baby Washes and Bath Liquid Hand Soaps

Shower Gels
Wet Wipe Solutions

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Examples of Cleansing Products


Bubble Bath Body Wash

Baby Wash Shower Gel

Bubble Bath

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Emulsions
An emulsion is a two phase system consisting of two completely immiscible liquids, one of which is dispersed in the other. Many types of Emulsions:
Oil-in-Water (O/W)

Water-in-Oil (W/O)
Multiple emulsions (O/W/O, W/O/W)

The majority of Skin Care Products are emulsions.

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Oil-in-Water Emulsions
Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (O/W). Advantages: Typically have better Aesthetics, easier to formulate, greater choice of emulsifiers, & lower cost. Disadvantage: Typically does not provide substantivity, water proofing and film formation.

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Oil in Water Emulsion


The surfactant maintains the small droplet size of the oil, keeps the droplets from aggregating (steric hinderance) and the surfactant/oil complex is soluble in the water. This is known as an oil in water emulsion (O/W)

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Example Products
StriVectin-SD Wrinkle and Stretch Mark Cream ($135) Water (Aqua), C12-15 Benzoate, Sesamum Indicum Seed Oil (Sesame), Caprylic/CapricTriglyceride, Prunus Amygdalus Dulcis Oil (Sweet Almond), Cetearyl Olivate, Sorbitan Olivate, Striadril Complex (see product details for ingredients list), Glycerin, Glyceryl Stearate and PEG-100 Stearate, PPG 12/SMDI Copolymer, Stearic Acid, Theobroma Cacao Seed Butter (Cocoa), Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate, Mangifera Indica (Mango), Mentha Piperita Oil (Peppermint), Methylparaben, Xanthan Gum, Triethanolamine, Butylparaben, Ethylparaben, Disodium EDTA, Propylparaben, Retinyl Palmitate, Tetrahexyldecyl Ascorbate Active Ingredients: 4% Octyl Salicylate, 2% Avobenzone, 1% Phenylbenzimidazole Sulfonic Acid, 1% Octocrylene Inactive Ingredients: Water, Glycerin, Dimethicone, Niacinamide (Vitamin B3), Isopropyl Isostearate, Polyacrylamide, Triethanolamine, Titanium Dioxide, C13-14 Isoparaffin, Cetearyl Glucoside, PTFE, Panthenol (Pro-Vitamin B5), Tocopheryl Acetate (Vitamin E), Stearyl Alcohol, Behenyl Alcohol, Cetyl Alcohol, Sucrose Polycottonseedate, Benzyl Alcohol, Dimethiconol, Carbomer, Methylparaben, Ethylparaben, Propylparaben, PEG 100 Stearate, Disodium EDTA, Laureth-7, Stearic Acid
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Example Products
Aveeno Baby Soothing Relief Moisture Cream, Fragrance Free
Water, Glycerin, Petrolatum, Mineral Oil, Cetyl Alcohol, Dimethicone, Avena Sativa (oat) Kernel Flour, Carbomer, Ceteareth 6, Ethylparaben, Sodium Citrate, Stearyl Alcohol, Propylparaben, Methylparaben, Sodium Hydroxide, Tetrasodium EDTA, Benzalkonium Chloride, Citric Acid, Butylparaben, Butylene Glycol, Hydrolyzed Milk Protein, PEG 25 Soy Sterol, Benzaldehyde, Hydrolyzed Oats, Hydroylzed Soy Protein, Isobutylparaben, Phenoxyethanol, Ethyl Alcohol

Aveeno Foot Cream, Intense Relief


Water, Glycerin, Petrolatum, Mineral Oil, Cetyl Alcohol, Dimethicone, Avena Sativa (oat) Kernel Flour, Butyrospermum Parkii (Shea Butter) Extract, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salicylic Acid, Menthyl Lactate, PEG 25, Soy Sterol, Carbomer, Ceteareth 6, Stearyl Alcohol, Tetrasodium EDTA, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, C12-16 Alkyl Hydroxyethyl Ethylcellulose, Sodium Citrate, 112 Benzalkonium Chloride, Citric Acid, Sodium Hydroxide

Water-in Oil Emulsions


Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (W/O). Advantages: Oil phase has direct contact with the skin, better film formation, and film is less water dispersible and continuous (water resistant and provides best protection). Disadvantage: Poor aesthetics and more costly.

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Water-in-Oil Emulsion

The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase
This is known as a water in oil emulsion (W/O)

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W/O Emulsions- Product Examples


Active Ingredients: Ointment contains:: Dimethicone 1% (diaper rash cream), Zinc Oxide 10% (diaper rash cream) Inactive Ingredients: Aloe Barbadensis Extract, Benzyl Alcohol, Coconut Oil, Cod Liver Oil (contains vitamin a & vitamin d), Fragrance, Glyceryl Oleate, Light Mineral Oil, Ozokerite, Paraffin, Propylene Glycol, Sorbitol, Synthetic Beeswax, Water

Active Ingredients: Zinc Oxide (10%) Inactive Ingredients: Water, Mineral Oil, Propylene Glycol Dioctanoate, Methyl Glucose Dioleate, Titanium Dioxide, PEG 45 Docecyl Glycol Copolymer, Glycerin, Ceresin, Ethyl Linoleate, Shea Butter, PEG 8, Panthenol, Potassium Sorbate, Fragrance, Magnesium Sulfate, Methylparaben, Caprylyl Glycol, Propylparaben, Sodium Polyacrylate

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Water-in-Oil Product Example

Philosophy hope in a tube, eye and lip firming cream


Water (aqua), Squalane, Mineral Oil, Glycerin, Isocetyl Stearoyl Stearate, Petrolatum, Butylene Glycol, Polyglyceryl 2 Diisostearate, PEG 30 Dipolyhydroxystearate, Ceresin, Polyethylene, Microcrystalline Wax, Magnesium Sulfate, Phytosteryl/Octyldodecyl/Lauroyl Glutamate, Dipalmitoyl Hydroxyproline, Tocopheryl Acetate, Polysorbate 80, Bisabolol, Potassium Ascorbyl Tocopheryl Phosphate, Iron Oxide (CI 77492, CI 77491 and CI77499), Methylparaben, Diazolidinyl Urea, Ethylparaben, Tetrasodium EDTA

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Multiple Emulsions
Emulsions formed when a W/O emulsion is emulsified in water or when an O/W emulsion is emusified in oil. Advantages: Good aesthetics and can provide protection of actives within the emulsion. Disadvantage: Can be difficult to stabilize.

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Emulsifying emulsions
With the addition of certain surfactants, an oil in water emulsion can be emulsified within an external oil phase. This is known as an oil in water in oil (O/W/O) emulsion

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Emulsifying Emulsions
With the addition of certain surfactants, a water in oil emulsion can be emulsified within an external water phase This is known as a water in oil in water (W/O/W) emulsion

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Suspensions
A dispersion of solid particles in a liquid medium.
Examples:
Anti-acids

Calamine Lotion (ZnO/FeO in Water)


Antiperspirants (Al salts in Silicone) Lipsticks (Pigments in Castor Oil and Waxes)

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Powders
Dry solids composed of numerous fine particles
Generally used to absorb moisture and or deliver active ingredients to the skin Examples:
Baby Powder Powder Make-ups Pressed Powders

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Conclusions
Cosmetic industry is extremely large and continues to grow yearly Multiple trends shape the industry and affect consumer buying intent

Multiple product types exist and changes occur due to consumer preference and technology shifts
Vast number of ingredients in the industry each with unique attributes and functionality Numerous formulations are used as delivery vehicles in the industry

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QUESTIONS?

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