Cosmetics

Phthalates

FDA has received a number of inquiries on the safety of phthalates, which are used in a variety of cosmetics as well as other consumer products. Here are answers to questions consumers often ask about these ingredients.


What are phthalates?

Phthalates are a group of chemicals used in hundreds of products, such as toys, vinyl flooring and wall covering, detergents, lubricating oils, food packaging, pharmaceuticals, blood bags and tubing, and personal care products, such as nail polish, hair sprays, aftershave lotions, soaps, shampoos, perfumes and other fragrance preparations.

How phthalates have been used in cosmetics

Historically, the primary phthalates used in cosmetic products have been dibutylphthalate (DBP), used as a plasticizer in products such as nail polishes (to reduce cracking by making them less brittle); dimethylphthalate (DMP), used in hair sprays (to help avoid stiffness by allowing them to form a flexible film on the hair); and diethylphthalate (DEP), used as a solvent and fixative in fragrances. According to FDA's latest survey of cosmetics, conducted in 2010, however, DBP and DMP are now used rarely. DEP is the only phthalate still commonly used in cosmetics.

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Phthalates and human health

It's not clear what effect, if any, phthalates have on human health. An expert panel convened from 1998 to 2000 by the National Toxicology Program (NTP), part of the National Institute for Environmental Safety and Health, concluded that reproductive risks from exposure to phthalates were minimal to negligible in most cases.

The Centers for Disease Control and Prevention (CDC) released a report on March 21, 2001, titled "National Report on Human Exposure to Environmental Chemicals." The report described a survey of a small segment of the U.S. population for environmental chemicals in urine. One group of chemicals surveyed was phthalates. However, the CDC survey was not intended to make an association between the presence of environmental chemicals in human urine and disease, but rather to learn more about the extent of human exposure to industrial chemicals.

In 2002, the Cosmetic Ingredient Review (CIR) Expert Panel reaffirmed its original conclusion (reached in 1985), finding that DBP, DMP, and DEP were safe as used in cosmetic products. (See “Annual Review of Cosmetic Ingredient Safety Assessments 2002/2003,” International Journal of Toxicology (Supplement 1), 1-102, 2005.) Looking at maximum known concentrations of these ingredients in cosmetics, the panel evaluated phthalate exposure and toxicity data, and conducted a safety assessment for dibutylphthalate in cosmetic products. The panel found that exposures to phthalates from cosmetics were low compared to levels that would cause adverse effects in animals. (The CIR is an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in open, peer-reviewed literature. FDA participates in CIR on a non-voting basis and may or may not accept CIR findings.)

FDA reviewed the safety and toxicity data for phthalates, including the CDC data from 2001, as well as the CIR conclusions based on reviews in 1985 and 2002. While the CDC report noted elevated levels of phthalates excreted by women of child-bearing age, neither this report nor the other data reviewed by FDA established an association between the use of phthalates in cosmetic products and a health risk. Based on this information, FDA determined that there wasn’t a sound, scientific basis to support taking regulatory action against cosmetics containing phthalates.

How FDA has followed up

FDA continues to monitor levels of phthalates in cosmetic products. We have developed an analytical method for determining the levels of phthalates in cosmetic products and conducted surveys of products to determine these levels in cosmetics on the market.

FDA published this analytical method and results of our 2004 survey in the article,“Analysis of Consumer Cosmetic Products for Phthalate Esters,” disclaimer icon (J.C. Hubinger and D.C. Havery, Journal of Cosmetic Science, 2006, vol. 57, pp. 127-137. We conducted a second survey in 2006. Results were published in the article, “A Survey of Phthalate Esters in Consumer Cosmetic Products," (PDF 488 KB) (J.C. Hubinger, Journal of Cosmetic Science, 2010, vol. 61, no. 6, pp. 457-465).  Results of a third survey, concluded in 2010, are shown below in the table, Laboratory Survey of Cosmetics Products for Phthalate Esters. We learned from these surveys that use of phthalates in cosmetics decreased considerably from 2004 to 2010.

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What we know about infant exposure to phthalates

Infants, like all consumers, are exposed daily to phthalates from a number of sources, including air, drugs, food, plastics, water, and cosmetics.

The American Academy of Pediatrics has published an article stating that infants exposed to infant care products, specifically baby shampoos, baby lotions, and baby powder, showed increased levels of phthalate metabolites in their urine (see “Baby Care Products: Possible Sources of Infant Phthalate Exposure,” disclaimer icon S. Sathyanarayana, Pediatrics, 2008, vol. 121, pp. 260-268).

Like the CDC report, this study did not establish an association between these findings and any health effects. In addition, levels of phthalates, if any, in the infant care products were not determined.

FDA included 24 children’s products intended for infants and children in the survey we completed in 2006, and nearly 50 products for infants and children in the survey we completed in 2010. What we learned was that the use of phthalates in cosmetics intended for people of all ages, including infants and children, has decreased considerably since our surveys began in 2004.

How to know if there are phthalates in the cosmetics you use

Under the authority of the Fair Packaging and Labeling Act (FPLA), FDA requires an ingredient declaration on cosmetic products sold at the retail level to consumers. Consumers can tell whether some products contain phthalates by reading the ingredient declaration on the labels of such products.

However, the regulations do not require the listing of the individual fragrance ingredients; therefore, the consumer will not be able to determine from the ingredient declaration if phthalates are present in a fragrance. Also, because the FPLA does not apply to products used exclusively by professionals--for example, in salons--the requirement for an ingredient declaration does not apply to these products. Based on available safety information, DEP does not pose known risks for human health as it is currently used in cosmetics and fragrances. Consumers who nevertheless do not want to purchase cosmetics containing DEP may wish to choose products that do not include "Fragrance" in the ingredient listing.

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FDA's role

Under the law, cosmetic products and ingredients, with the exception of color additives, are not subject to FDA approval before they go on the market. FDA can take action against unsafe cosmetics that are on the market, but only if we have dependable scientific evidence showing that a product or ingredient is unsafe for consumers under labeled or customary conditions of use.

At the present time, FDA does not have evidence that phthalates as used in cosmetics pose a safety risk. If we determine that a health hazard exists, we will advise the industry and the public, and will take action within the scope of our authority under the Federal Food, Drug, and Cosmetic Act in protecting the health and welfare of consumers.

For related information, see FDA Authority Over Cosmetics and How FDA Evaluates Regulated Products: Cosmetics.

Results of FDA's 2010 Survey of Cosmetics for Phthalate Content

The products listed below represent a sample of cosmetics on the market at the time the survey was conducted, and products may have been reformulated since then. This survey was intended to monitor trends in the use of phthalates in cosmetics, not as a comprehensive analysis of all cosmetics on the market. The law does not require cosmetic firms to file their formulations with FDA. Also, please note that some so-called "personal care products," such as diaper creams and nipple creams, are regulated as drugs, or in some cases both cosmetics and drugs. (See "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)")

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2010 Survey of Cosmetics for Phthalate Content

Product Type

Brand

Lot #

Phthalates (ppm)
DMPDEPDBP
Nail Polish
Pure Ice - Spit Fire991CP   
Dora the Explorer Mega Nail Polish Kit - TownleyWO90817   
Scherer Nail Polish CQ #143 CabernetNot visible   
Rimmel Lycra Wear 10 Days Nail Polish #303 Vintage732318   
In a New York Color Minute 224B8MBCK   
Sally Hansen Diamond Strength #45 Fuchsia8MSHK   
Hard Candy Just Nails (Glitter)9226   
Petites Pink Crush 270 – CQNot visible   
Revlon Nail Enamel Red Hot Tamale 908Not visible   
Maybelline Express Finish Grape Times 608WF224   
Nicole by OPI Razzle Dazzler09295AAG   
Scherer Nail Polish CQ #107 Crystal ClearNot visible   
LA Colors Nail Lacquer Red Stilettos CBLQ 389Not visible   
LA Colors Art Deco Polish Silver Glitter CBNA 502Not visible   
LA Colors Nail Hardener-Strengthener9796   
Hot Topic Nail Polish BlackNot visible   
Hot Topic Nail Polish GreenNot visible   
Hot Topic Nail Polish PurpleNot visible   
Hot Topic Nail Polish (Skull) GreenNot visible  4,800
Hot Topic Nail Polish (Skull) BlackNot visible  4.4
Hot Topic Nail Polish (Skull) YellowNot visible  4
Simple Pleasures Nail Polish "Peace" (Glitter)Not visible   
Simple Pleasures Nail Polish "Love" (Pink)Not visible   
WetnWild Wild Shine 410A918201   
Sinful Colors Professional Nail Polish Enamel Pinky Glitter 830Not visible   
Sinful Colors Under 18Not visible   
Borghese Nail Lacquer Vernis Botticelli Nude6KXJKC  3.4
Sally Hansen High Definition 04 (Green)9MHYK   
Cover Girl Boundless Base Coat Nail Color Red Revolution 5537239HV   
Cover Girl Boundless Base Coat Nail Color Gold Rush 4159139HV   
Sally Hansen Hard As Nails Xtreme Wear Hot Magenta 036MTXK   
Sally Hansen Salon Lacquer Nail Polish Orange You Cute? 4508JFDK  6.6
Sally Hansen Insta-Dri Rose-a-go-go 06AKVDKN   
Sally Hansen Diamond Strength 33 Champagne Toast8M8OK   
Avon Nailwear Pro Nail Enamel Polish Midnight PlumVEK19   
Skin Cream and Lotion
Red Velvet Body Lotion - Gift PackH8920109   
Dove Deep Moisture Nourishing Body Wash with NutrimMoisture10079PP23S   
Eucerin Plus Intensive Repair Hand Crème with Dry Skin Therapy90125515   
Aveeno Active Naturals Daily Moisturizing Lotion1129LK   
Vaseline Sheer Infusion Vitamin Burst Body Lotion08149UM42   
Palmer's Cocoa Butter Formula Concentrated CreamN9215A   
Jergens Ultra Healing Extra Dry Skin MoisturizerY225106ZZA   
Ponds Dry Skin Cream08289HU87   
Dollar General Guarantee Skin Rescue Moisture Lock LotionC9A129   
Noxzema The Original Deep Cleansing Cream with Eucalyptus OilRubbed out   
Suave Powder Fresh Body Lotion10289JU41   
Celine Dion Sensational Shimmering Body Lotion92251   
Scentsations by Body Source Cherry Blossom Body LotionM9290AL18   
Walgreens Advanced Care (Fragrance Free)0401609   
Curel Continuous Comfort Original Formula MoisturizerX140106ZZA   
Lubriderm Daily Moisture Lotion, Normal to Dry Skin, Fragrance Free0118C   
Nivea Soft Refreshingly Soft Moisturizing Crème73729160 100 
Bath, Body, etc… Organic Soothing Aloe Vera Body Lotion29473 260 
J.R. Watkins Natural Apothecary Hand & Body Lotion0374579   
Jergens Original Scent Cherry-Almond MoisturizerW106125ZZ 110 
Palmer’s Cocoa Butter Formula with Vitamin E Skin Therapy OilRubbed out   
St. Ives Hydrating Vitamin E Advanced Body Moisturizer09327021103   
Vaseline for Men Hand Lotion05279HU09   
Corn Huskers Heavy Duty Oil-Free Hand Treatment Lotion2969G   
Malibu Hemp Moisturizer Body Lotion for Dry Skin5434   
Keri Original Dry Skin Lotion23654901   
Avon Haiku Perfumed Skin SoftenerMK091   
Avon Jet Femme Body LotionMLP81   
Avon Candid Perfumed Skin SoftenerMAN91   
Avon Moisture Therapy Intensive Extra Strength CreamMIV91   
Fragrance
Dove Go Fresh Body Mist090495U49   
Jovan Island Gardenia Cologne Spray9218 14,000 
Love’s Baby Soft Cologne Spray0906D48   
A Little Sexy Body Spray by Parfums de Coeur09324   
Axe Instinct Body Spray03119KK09   
Curve Crush Body Mist9JA02   
Bodycology Sweet Petals Body MistS9J27AK   
Cotton Candy Body Spray Prince Matchabelli09267   
Degree Classic Romance Body Mist4068   
Hannah Montana Cologne Spray3169Y   
Wanna Play Body Spray Parfums de Coeur09294 3,800 
Chantilly - Walmart Gift Pack090723A 7,300 
Tabu - Walmart Gift Pack090721A 6,200 
Heaven Sent - Walmart Gift Pack090622B 1,300 
Navy - Walmart Gift Pack090722C 40,000 
English Leather - Walmart Gift Pack090721A 3,900 
British Sterling - Walmart Gift Pack090526A 480 
Canoe - Walmart Gift Pack0907248 2,000 
English Leather Black - Walmart Gift Pack0907916   
Johnson's Baby Cologne1919COB128135   
Barbasol After Shave Pacific Rush60161   
Aqua Velva Classic Ice BlueR09K174 760 
Tattooed by InkyNot visible   
BOD Really Ripped Abs8TZ60 6,200 
i Carly168961B   
Baby Cream and Lotion
Johnson's Baby Lotion2519T   
Dollar General Sleepy Time Baby Lotion8KF1025   
Baby Avalon Organics Protective A,D & E Ointment6H01   
Huggies Naturally Refreshing (Green Tea & Cucumber) LotionCU6287282   
Baby Magic Gentle Baby Lotion9237   
Burt's Bees Baby Bee Buttermilk Lotion0850801   
Aveeno Baby Soothing Relief Moisture Cream0209D   
Parent's Choice Baby Lotion0034311   
Johnson's Bedtime Lotion1759G   
Johnson's Head-to-Toe Fragrance Free Baby Lotion0049LK   
Johnson's Shea and Cocoa Butter Baby Cream0069VB   
Susan Brown's Baby Sensitive Baby Lotion-to-powder10577A   
California Baby Calming Everyday LotionCB9303A2   
Deodorant
Brut 24-Hour Protection deodorant11029TR53 22 
Tom's of Maine Natural Care Lavender Deodorant StickLD1370   
Old Spice High Endurance Deodorant9307TN   
Axe Fresh Action Essence Deodorant08129UR16   
Degree Men Deodorant Silver Ion Intense Sport11209UR392.9  
Speed Stick Ocean Surf Deodorant9270502   
Personal Care Clear Stick Deodorant08123A   
Kiss My Face Active Enzyme Lavender DeodorantKO73008B   
Dove Powder Invisible Solid09229UR86   
Secret Powder Fresh9068TN 34 
Hair Products
Biosilk Rock Hard Gelee Firm HoldC8200   
Garnier Fructis Style Body Boost Volumizing Gel48F6030   
TRESemmé No Frizz Shine Spray09308TA20SDSIL2506 22 
Suave Professionals Styling Foam Extra Hold11129KK61 52 
Rave 4X Mega Unscented Hair Spray11199HU63 16 
White Rain Unscented Extra Hold Hair Spray287CP3475403SDSIL15001 61 
Short Sexy Hair Quick Change Shaping Balm09219   
American Crew Forming CreamF952CIOC 50 
Dep Sport Endurance Styling GelR2029932A2 6.8 
TRESemme Tres Two Extra Hold Hair Spray09313AA1416 37 
John Frieda Collection Frizz-Ease MousseY223DK17DDT2Q   
Aussi Catch the Wave Mousse & Conditioner92755398F   
Catwalk Extra Strong Mousse233748783122142 23 
Johnson's No More Tangles Detangling Spray0489VA   
Manic Panic Amplified Semi-Permanent Hair Color Cream10922   
Color Fiend Blood Red Temporary Comb-In ColorRN0709   
Color Fiend Pink Pop Water Based Semi-Permanent Hair ColorNot visible   
Shampoo
Johnson's Baby Shampoo2118T   
Suave Kids 2 in 1 Shampoo Smoothers Cowabunga Coconut081491J18   
Ave Dual 2 in 1 Shampoo + Conditioner01139TJ27 17 
Pantene Pro-v Moisture Renewal Hydration Quotidienne Shampoo93005401E1   
Aveeno Baby Essential Moisture Shampoo0099VA   
Big Sexy Hair Big Volume Shampoo09205150 210 
Garnier Fructis Fortifying Shampoo Color ShieldEF036   
Dove Intense Damage Therapy Shampoo08299JU39   
VO5 Normal Balancing Shampoo09316020758 440 
Suave Professionals Sleek Shampoo07109JU41   
Finesse Self Adjusting Moisturizing Shampoo9234M   
Herbal Essences Hello Hydration Moisturizing Shampoo93145395LF   
TRESemmé Smooth and Silky Touchable Softness09231C1130   
Advance Techniques Color Reviving ShampooMK191 82 
Avon High School Musical Raspberry Roarin’ 2-in-1 ShampooMKW91   
Body Wash
Caress Daily Silk Silkening Body Wash10159UR022010   
Equate Tropical Fresh Body Wash with Exfoliating Pomegranate SeedA50298-9328C1   
Caress Tahitian Renewal Silkening Body Wash08069TJ37   
Olay Body Ultra Moisture with Shea Butter Body Wash92595395WA   
Suave Naturals Cucumber Melon Rejuvenating Body Wash11109J038   
Suave Men Body Wash Active Sport09169CU05 10 
White Rain All Day Moisturizing Body Wash093203   
Dove Sensitive Skin Beauty Body Wash03049PP05   
Natural Concepts Sensitive Skin Body WashA48292926583 340 
Dial Clean and Soft Moisturizing Body WashQ89M0310806091102   
St. Ives Renewing Collagen Elastin Moisturizing Body Wash09345181020141   
Natural Concepts Natural Blends Body Wash Violet & PeaA40128-8353C1   
Avon Naturals Strawberry & Guava Shower GelRubbed out   
Avon Bubble Bath Bain-mousse Vanilla Cream for Dry SkinMLK91   
High School Musical Strawberry Sudsin’ Body WashMLC91   
Nipple Cream
Lansinoh HPA Lanolin for Breastfeeding Mothers39982   
Gerber Breast Therapy Moisturizing BalmBK07A02UU   
Children's Makeup
Kiss Me 2 Gift Pack Blush - Markwins    
Kiss Me 2 Gift Pack Eye Shadow - Markwins1090075   
Hard Candy in the Shadows Eye Shadow Collection9260   
Claire's Cosmetics Eye Shadow11/09   
Claire's Cosmetics Eye GlitterDR911333   
Diaper Cream
Butt Butter Organics Herbal Diaper Rash Treatment31823   
Burts Bees Baby Bee Diaper Ointment1070801   
Baby’s Bliss Diaper Cream1386 130 
Lavera Baby & Kinder Neutral2897   
Weleda Baby Calendula Baby Cream902212   
Wet Wipes
Pull-ups Flushable Moist WipesMK929202A   
Equate Flushable Wipes All Purpose09295D209651416   
Pure'n Gentle Fragrance Free Wipes09272C230400512   
Huggies Soft Skin Baby WipesMK914804A   
My Fair Baby Baby Wipes38091679169   
Infant Soap, Shampoo, Body Wash
Johnson's Head to Toe Baby WashRubbed out   
Body Sense Baby Wash with Shea & Cocoa butterOU28781   
My Fair Baby Baby Wash with Camomile608015001/A2 60 
Burts Bees Baby Bees Shampoo and Wash2280801   
Avon Bubble Bath Bain-mousse for KidsMKY91   
Aubrey Organics - Natural Baby & Kids Bath Soap11249   
Baby Oil
Johnson's Baby Oil2339G   
Equate Delicate Baby Oil0031646   
Burt's Bees Baby Bee Apricot Baby Oil0460801   
Face & Body Paint
Claire's Cosmetics Body Glitter07/09   
Claire's Cosmetics Vanilla Glitter Body Mist0929301 390 
Alex Face Paint Studio - Face Paint9012LP   
Snazaroo Face Painting KitT190803   
Glitter Gel
Hard Candy Glitteratzi Eye Glitter Gel9301   
Claire's Club Scented Body Glitter4926 167 
Alex Face Paint Studio - Pink Glitter Gel9B2351   
Baby Powder
Johnson's Baby Powder2528RA   
Body Sense Baby Powder9DG0797   
Burt's Bees Baby Bee Dusting PowderNot visible   

April 19, 2001; Updated March 31, 2005, February 7, 2008, and December 5, 2013

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