Phthalates in Cosmetics
Phthalates are used in a variety of cosmetics and personal care products. Phthalates are chemical compounds developed in the last century that are used to make plastics more durable. These colorless, odorless, oily liquids also referred to as “plasticizers” based on their most common uses. They do not evaporate easily and do not permanently bind to plastic surfaces to which they are applied. Phthalates also function as solvents and stabilizers in perfumes and other fragrance preparations. Cosmetics that may contain phthalates include nail polishes, hair sprays, aftershave lotions, cleansers, and shampoos.
How to Know if Phthalates are in the Cosmetics You Use
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 the FDA's latest survey of cosmetics, conducted in 2010, however, DBP and DMP are used rarely. DEP appears to be the only phthalate still commonly used in cosmetics.
Under the authority of the Fair Packaging and Labeling Act (FPLA), the 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 or flavor, or their specific ingredients. Fragrance or flavor may be listed as such. As a result, a consumer may not be able to determine from the ingredient declaration on the label if phthalates are present in a fragrance or a flavor used in the product. Based on currently available safety information, the FDA does not have safety concerns with the use of DEP as 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" or “Flavor” in the ingredient declaration.
Possible Health Effects of Phthalates in Cosmetics
The FDA considers all available scientific literature on the safety of phthalates in cosmetics published by the scientific community.
In 2002, the Cosmetic Ingredient Review (CIR) Expert Panel, an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in open, peer-reviewed literature, 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 DBP in cosmetic products. The panel found that levels of exposures to phthalates from cosmetics were low compared to levels that may cause adverse effects in animals.
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 to learn more about the extent of human exposure to industrial chemicals. One group of chemicals surveyed was phthalates. 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 the FDA established an association between the use of phthalates in cosmetic products and a health risk. Based on this information, the FDA determined that there wasn’t a sound, scientific basis to support taking regulatory action against cosmetics containing phthalates.
An expert panel convened by the National Toxicology Program, part of the National Institute of Environmental Health Sciences, from 1998 to 2000, concluded that reproductive risks from exposure to phthalates were minimal.
As the FDA continues to follow the ongoing scientific discussions, we will consider additional actions as needed.
The FDA's Role in Regulating Phthalates in Cosmetics
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. Cosmetics must be safe under the labeled or customary conditions of use, and the FDA can take action against cosmetics on the market that do not comply with the law.
At the present time, the 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 to protect consumers within the scope of our authority under the Federal Food, Drug, and Cosmetic Act. For related information, see FDA Authority Over Cosmetics.
The FDA’s Continued Evaluation of Phthalates in Cosmetics
The FDA continues to monitor levels of phthalates in cosmetic products. We have developed an analytical method for determining the levels of phthalates in a survey of marketed cosmetic products.
The 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, 2010 Survey of Cosmetics for Phthalate Content. We learned from these surveys that use of phthalates in cosmetics decreased considerably from 2004 to 2010.
Infant Exposure to Phthalates in Personal Care Products
Infants, like all consumers, are exposed daily to phthalates from a number of sources, including air, drugs, food (including breast milk), plastics, water, and cosmetics. The American Academy of Pediatrics 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,” S. Sathyanarayana, Pediatrics, 2008, vol. 121, pp. 260-268). This biomonitoring study was not designed to establish an association between these findings and any adverse health effects. In addition, levels of phthalates, if any, in the infant care products were not determined in this study.
In its survey that was completed in 2006, the FDA included 24 children’s products intended for infants and children, and included nearly 50 products for infants and children in the survey we completed in 2010. We learned 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.
Results of the 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 the 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?)")
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 | ||||