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  1. Cosmetic Products & Ingredients

Phthalates

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.

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,” (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.

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.

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)
DMP DEP DBP
Nail Polish
Pure Ice - Spit Fire 991CP      
Dora the Explorer Mega Nail Polish Kit - Townley WO90817      
Scherer Nail Polish CQ #143 Cabernet Not visible      
Rimmel Lycra Wear 10 Days Nail Polish #303 Vintage 732318      
In a New York Color Minute 224B 8MBCK      
Sally Hansen Diamond Strength #45 Fuchsia 8MSHK      
Hard Candy Just Nails (Glitter) 9226      
Petites Pink Crush 270 – CQ Not visible      
Revlon Nail Enamel Red Hot Tamale 908 Not visible      
Maybelline Express Finish Grape Times 608 WF224      
Nicole by OPI Razzle Dazzler 09295AAG      
Scherer Nail Polish CQ #107 Crystal Clear Not visible      
LA Colors Nail Lacquer Red Stilettos CBLQ 389 Not visible      
LA Colors Art Deco Polish Silver Glitter CBNA 502 Not visible      
LA Colors Nail Hardener-Strengthener 9796      
Hot Topic Nail Polish Black Not visible      
Hot Topic Nail Polish Green Not visible      
Hot Topic Nail Polish Purple Not visible      
Hot Topic Nail Polish (Skull) Green Not visible     4,800
Hot Topic Nail Polish (Skull) Black Not visible     4.4
Hot Topic Nail Polish (Skull) Yellow Not visible     4
Simple Pleasures Nail Polish "Peace" (Glitter) Not visible      
Simple Pleasures Nail Polish "Love" (Pink) Not visible      
WetnWild Wild Shine 410A 918201      
Sinful Colors Professional Nail Polish Enamel Pinky Glitter 830 Not visible      
Sinful Colors Under 18 Not visible      
Borghese Nail Lacquer Vernis Botticelli Nude 6KXJKC     3.4
Sally Hansen High Definition 04 (Green) 9MHYK      
Cover Girl Boundless Base Coat Nail Color Red Revolution 553 7239HV      
Cover Girl Boundless Base Coat Nail Color Gold Rush 415 9139HV      
Sally Hansen Hard As Nails Xtreme Wear Hot Magenta 03 6MTXK      
Sally Hansen Salon Lacquer Nail Polish Orange You Cute? 450 8JFDK     6.6
Sally Hansen Insta-Dri Rose-a-go-go 06 AKVDKN      
Sally Hansen Diamond Strength 33 Champagne Toast 8M8OK      
Avon Nailwear Pro Nail Enamel Polish Midnight Plum VEK19      
Skin Cream and Lotion
Red Velvet Body Lotion - Gift Pack H8920109      
Dove Deep Moisture Nourishing Body Wash with NutrimMoisture 10079PP23S      
Eucerin Plus Intensive Repair Hand Crème with Dry Skin Therapy 90125515      
Aveeno Active Naturals Daily Moisturizing Lotion 1129LK      
Vaseline Sheer Infusion Vitamin Burst Body Lotion 08149UM42      
Palmer's Cocoa Butter Formula Concentrated Cream N9215A      
Jergens Ultra Healing Extra Dry Skin Moisturizer Y225106ZZA      
Ponds Dry Skin Cream 08289HU87      
Dollar General Guarantee Skin Rescue Moisture Lock Lotion C9A129      
Noxzema The Original Deep Cleansing Cream with Eucalyptus Oil Rubbed out      
Suave Powder Fresh Body Lotion 10289JU41      
Celine Dion Sensational Shimmering Body Lotion 92251      
Scentsations by Body Source Cherry Blossom Body Lotion M9290AL18      
Walgreens Advanced Care (Fragrance Free) 0401609      
Curel Continuous Comfort Original Formula Moisturizer X140106ZZA      
Lubriderm Daily Moisture Lotion, Normal to Dry Skin, Fragrance Free 0118C      
Nivea Soft Refreshingly Soft Moisturizing Crème 73729160   100  
Bath, Body, etc… Organic Soothing Aloe Vera Body Lotion 29473   260  
J.R. Watkins Natural Apothecary Hand & Body Lotion 0374579      
Jergens Original Scent Cherry-Almond Moisturizer W106125ZZ   110  
Palmer’s Cocoa Butter Formula with Vitamin E Skin Therapy Oil Rubbed out      
St. Ives Hydrating Vitamin E Advanced Body Moisturizer 09327021103      
Vaseline for Men Hand Lotion 05279HU09      
Corn Huskers Heavy Duty Oil-Free Hand Treatment Lotion 2969G      
Malibu Hemp Moisturizer Body Lotion for Dry Skin 5434      
Keri Original Dry Skin Lotion 23654901      
Avon Haiku Perfumed Skin Softener MK091      
Avon Jet Femme Body Lotion MLP81      
Avon Candid Perfumed Skin Softener MAN91      
Avon Moisture Therapy Intensive Extra Strength Cream MIV91      
Fragrance
Dove Go Fresh Body Mist 090495U49      
Jovan Island Gardenia Cologne Spray 9218   14,000  
Love’s Baby Soft Cologne Spray 0906D48      
A Little Sexy Body Spray by Parfums de Coeur 09324      
Axe Instinct Body Spray 03119KK09      
Curve Crush Body Mist 9JA02      
Bodycology Sweet Petals Body Mist S9J27AK      
Cotton Candy Body Spray Prince Matchabelli 09267      
Degree Classic Romance Body Mist 4068      
Hannah Montana Cologne Spray 3169Y      
Wanna Play Body Spray Parfums de Coeur 09294   3,800  
Chantilly - Walmart Gift Pack 090723A   7,300  
Tabu - Walmart Gift Pack 090721A   6,200  
Heaven Sent - Walmart Gift Pack 090622B   1,300  
Navy - Walmart Gift Pack 090722C   40,000  
English Leather - Walmart Gift Pack 090721A   3,900  
British Sterling - Walmart Gift Pack 090526A   480  
Canoe - Walmart Gift Pack 0907248   2,000  
English Leather Black - Walmart Gift Pack 0907916      
Johnson's Baby Cologne 1919COB128135      
Barbasol After Shave Pacific Rush 60161      
Aqua Velva Classic Ice Blue R09K174   760  
Tattooed by Inky Not visible      
BOD Really Ripped Abs 8TZ60   6,200  
i Carly 168961B      
Baby Cream and Lotion
Johnson's Baby Lotion 2519T      
Dollar General Sleepy Time Baby Lotion 8KF1025      
Baby Avalon Organics Protective A,D & E Ointment 6H01      
Huggies Naturally Refreshing (Green Tea & Cucumber) Lotion CU6287282      
Baby Magic Gentle Baby Lotion 9237      
Burt's Bees Baby Bee Buttermilk Lotion 0850801      
Aveeno Baby Soothing Relief Moisture Cream 0209D      
Parent's Choice Baby Lotion 0034311      
Johnson's Bedtime Lotion 1759G      
Johnson's Head-to-Toe Fragrance Free Baby Lotion 0049LK      
Johnson's Shea and Cocoa Butter Baby Cream 0069VB      
Susan Brown's Baby Sensitive Baby Lotion-to-powder 10577A      
California Baby Calming Everyday Lotion CB9303A2      
Deodorant
Brut 24-Hour Protection deodorant 11029TR53   22  
Tom's of Maine Natural Care Lavender Deodorant Stick LD1370      
Old Spice High Endurance Deodorant 9307TN      
Axe Fresh Action Essence Deodorant 08129UR16      
Degree Men Deodorant Silver Ion Intense Sport 11209UR39 2.9    
Speed Stick Ocean Surf Deodorant 9270502      
Personal Care Clear Stick Deodorant 08123A      
Kiss My Face Active Enzyme Lavender Deodorant KO73008B      
Dove Powder Invisible Solid 09229UR86      
Secret Powder Fresh 9068TN   34  
Hair Products
Biosilk Rock Hard Gelee Firm Hold C8200      
Garnier Fructis Style Body Boost Volumizing Gel 48F6030      
TRESemmé No Frizz Shine Spray 09308TA20SDSIL2506   22  
Suave Professionals Styling Foam Extra Hold 11129KK61   52  
Rave 4X Mega Unscented Hair Spray 11199HU63   16  
White Rain Unscented Extra Hold Hair Spray 287CP3475403SDSIL15001   61  
Short Sexy Hair Quick Change Shaping Balm 09219      
American Crew Forming Cream F952CIOC   50  
Dep Sport Endurance Styling Gel R2029932A2   6.8  
TRESemme Tres Two Extra Hold Hair Spray 09313AA1416   37  
John Frieda Collection Frizz-Ease Mousse Y223DK17DDT2Q      
Aussi Catch the Wave Mousse & Conditioner 92755398F      
Catwalk Extra Strong Mousse 233748783122142   23  
Johnson's No More Tangles Detangling Spray 0489VA      
Manic Panic Amplified Semi-Permanent Hair Color Cream 10922      
Color Fiend Blood Red Temporary Comb-In Color RN0709      
Color Fiend Pink Pop Water Based Semi-Permanent Hair Color Not visible      
Shampoo
Johnson's Baby Shampoo 2118T      
Suave Kids 2 in 1 Shampoo Smoothers Cowabunga Coconut 081491J18      
Ave Dual 2 in 1 Shampoo + Conditioner 01139TJ27   17  
Pantene Pro-v Moisture Renewal Hydration Quotidienne Shampoo 93005401E1      
Aveeno Baby Essential Moisture Shampoo 0099VA      
Big Sexy Hair Big Volume Shampoo 09205150   210  
Garnier Fructis Fortifying Shampoo Color Shield EF036      
Dove Intense Damage Therapy Shampoo 08299JU39      
VO5 Normal Balancing Shampoo 09316020758   440  
Suave Professionals Sleek Shampoo 07109JU41      
Finesse Self Adjusting Moisturizing Shampoo 9234M      
Herbal Essences Hello Hydration Moisturizing Shampoo 93145395LF      
TRESemmé Smooth and Silky Touchable Softness 09231C1130      
Advance Techniques Color Reviving Shampoo MK191   82  
Avon High School Musical Raspberry Roarin’ 2-in-1 Shampoo MKW91      
Body Wash
Caress Daily Silk Silkening Body Wash 10159UR022010      
Equate Tropical Fresh Body Wash with Exfoliating Pomegranate Seed A50298-9328C1      
Caress Tahitian Renewal Silkening Body Wash 08069TJ37      
Olay Body Ultra Moisture with Shea Butter Body Wash 92595395WA      
Suave Naturals Cucumber Melon Rejuvenating Body Wash 11109J038      
Suave Men Body Wash Active Sport 09169CU05   10  
White Rain All Day Moisturizing Body Wash 093203      
Dove Sensitive Skin Beauty Body Wash 03049PP05      
Natural Concepts Sensitive Skin Body Wash A48292926583   340  
Dial Clean and Soft Moisturizing Body Wash Q89M0310806091102      
St. Ives Renewing Collagen Elastin Moisturizing Body Wash 09345181020141      
Natural Concepts Natural Blends Body Wash Violet & Pea A40128-8353C1      
Avon Naturals Strawberry & Guava Shower Gel Rubbed out      
Avon Bubble Bath Bain-mousse Vanilla Cream for Dry Skin MLK91      
High School Musical Strawberry Sudsin’ Body Wash MLC91      
Nipple Cream
Lansinoh HPA Lanolin for Breastfeeding Mothers 39982      
Gerber Breast Therapy Moisturizing Balm BK07A02UU      
Children's Makeup
Kiss Me 2 Gift Pack Blush - Markwins        
Kiss Me 2 Gift Pack Eye Shadow - Markwins 1090075      
Hard Candy in the Shadows Eye Shadow Collection 9260      
Claire's Cosmetics Eye Shadow 11/09      
Claire's Cosmetics Eye Glitter DR911333      
Diaper Cream
Butt Butter Organics Herbal Diaper Rash Treatment 31823      
Burts Bees Baby Bee Diaper Ointment 1070801      
Baby’s Bliss Diaper Cream 1386   130  
Lavera Baby & Kinder Neutral 2897      
Weleda Baby Calendula Baby Cream 902212      
Wet Wipes
Pull-ups Flushable Moist Wipes MK929202A      
Equate Flushable Wipes All Purpose 09295D209651416      
Pure'n Gentle Fragrance Free Wipes 09272C230400512      
Huggies Soft Skin Baby Wipes MK914804A      
My Fair Baby Baby Wipes 38091679169      
Infant Soap, Shampoo, Body Wash
Johnson's Head to Toe Baby Wash Rubbed out      
Body Sense Baby Wash with Shea & Cocoa butter OU28781      
My Fair Baby Baby Wash with Camomile 608015001/A2   60  
Burts Bees Baby Bees Shampoo and Wash 2280801      
Avon Bubble Bath Bain-mousse for Kids MKY91      
Aubrey Organics - Natural Baby & Kids Bath Soap 11249      
Baby Oil
Johnson's Baby Oil 2339G      
Equate Delicate Baby Oil 0031646      
Burt's Bees Baby Bee Apricot Baby Oil 0460801      
Face & Body Paint
Claire's Cosmetics Body Glitter 07/09      
Claire's Cosmetics Vanilla Glitter Body Mist 0929301   390  
Alex Face Paint Studio - Face Paint 9012LP      
Snazaroo Face Painting Kit T190803      
Glitter Gel
Hard Candy Glitteratzi Eye Glitter Gel 9301      
Claire's Club Scented Body Glitter 4926   167  
Alex Face Paint Studio - Pink Glitter Gel 9B2351      
Baby Powder
Johnson's Baby Powder 2528RA      
Body Sense Baby Powder 9DG0797      
Burt's Bees Baby Bee Dusting Powder Not visible      

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

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