EWG's Skin Deep®

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Ingredient has a concern that requires further explanation

Understanding this score

Retinoids public facing statement for Skin Deep

This ingredient's score is higher if a product contains it at levels above the concentration determined to be safe by EWG’s risk assessment, 0.01 parts per million retinol equivalence. EWG used National Toxicology Program data on retinoid exposure in mice and the development of skin cancer lesions to calculate a safe level of retinoids in a product. The ingredient score will be lower if the total concentration of retinoids in the product is at or below EWG’s calculated safe level.

Data: Fair

Retinyl Palmitate (Vitamin A Palmitate)

Products with this ingredient are allowed for use in EWG VERIFIED but must meet use restrictions and warnings based on EWG review of company data.
This ingredient's score is higher if used in product forms that are inhalable (e.g., sprays, powders) because of respiratory concerns. The score is lower if used in product forms that have lower risk of inhalation (e.g., solids, liquids)
This ingredient's score is higher if used in products that may not meet industry safety guidelines or U.S. and international government requirements. The score will be lower if used in products that meet these safety guidelines and requirements.

IMAGE SOURCE: PubChem

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Other Concerns

Enhanced skin absorption, Use restrictions (high), Non-reproductive organ system toxicity (low), and Biochemical or cellular level changes (high)

SYNONYMS

● RETINYL PALMITATE (VITAMIN A PALMITATE; RETINOL PALMITATE)

● SR-05000001910

● A839762

● RETINYL PALMITATE SOLUTION, 100 MUG/ML (ETHANOL WITH 0.1% (W/V) BHT), AMPULE OF 1 ML, CERTIFIED REFERENCE MATERIAL

● UNII-81G40H8B0T COMPONENT VYGQUTWHTHXGQB-FFHKNEKCSA-N

● SR-05000001910-1

● AB00052360_04

● D00164

● C02588

● RETINYL PALMITATE, POTENCY: >=1,700,000 USP UNITS PER G

Restricted - Unaccpetable

The score of this ingredient can vary from Restricted to Unacceptable based on the method of product consumption. For instance, when used in aerosol-based products, this ingredient may pose a risk to respiratory health, leading to a higher score

Click here for more information about ingredient scores

Retinyl palmitate is an ingredient composed of palmitic acid and retinol (Vitamin A). When exposed to UV light, retinol compounds break down and produce toxic free radicals that can damage DNA and cause gene mutations, a precursor to cancer. Recently available data from an FDA study indicate that retinyl palmitate, when applied to the skin in the presence of sunlight, may speed the development of skin tumors and lesions. FDA also raised a concern that extensive, daily skin application of vitamin A creams may build up in the womanäó»s body a high enough level of Vitamin A that may be toxic to the developing fetus.

Common concerns

See how this product scores for common concerns.

LOW_MODERATE

Cancer
LOW

Allergies & Immunotoxicity
HIGH

Developmental and Reproductive Toxicity
HIGH

Use Restrictions

Ingredient concerns

CONCERNS
DATA SOURCES

Products with this Ingredient

facial moisturizer/treatment	206 products
conditioner	174 products
hair treatment/serum	107 products
skin fading/lightener	4 products
body wash/cleanser	53 products
shampoo	114 products
sunless tanning	11 products
damaged skin treatment	4 products
styling gel/lotion	22 products
shaving cream (men's)	8 products
oil controller	1 products
hair styling aid	41 products
styling mousse/foam	4 products
anti-aging	41 products
mask	86 products
hair spray	19 products
bronzer/highlighter	24 products
eye shadow	14 products
facial powder	37 products
tanning oil	6 products
facial cleanser	92 products
after shave	9 products
exfoliant/scrub	142 products
baby lotion	17 products
diaper cream	6 products
lipstick	283 products
moisturizer	273 products
body powder	2 products
concealer	177 products
after sun product	14 products
hand cream	34 products
foot moisturizer	6 products
makeup primer	37 products
nail treatment	20 products
foundation	379 products
hair relaxer	2 products
hair-loss treatment	12 products
detangler	9 products
body oil	13 products
baby oil	6 products
hand sanitizer	9 products
body firming lotion	48 products
blush	23 products
mascara	19 products
cuticle treatment	4 products
polish remover	6 products
body spray	2 products
bubble bath	2 products
serums & essences	113 products
lip gloss	61 products
liquid hand soap	14 products
Oils & Serums	7 products
muscle/joint soreness	6 products
bath oil/salts/soak	9 products
lip balm	20 products
nail polish	15 products
around-eye cream	60 products
antiperspirant/deodorant (men's)	2 products
daily use with SPF	41 products
baby soap	8 products
baby shampoo	8 products
recreational sunscreen	24 products
lip balm with SPF	6 products
baby sunscreen	2 products
bar soap	9 products
brow liner	21 products
shaving cream	5 products
BB cream	16 products
baby bubble bath	3 products
eye liner	16 products
setting powder/spray	18 products
toners/astringents	14 products
foot cleansing	2 products
makeup remover	3 products
toothpaste	5 products
hair color and bleaching	8 products
lip liner	1 products
tooth whitening	1 products
pore strips	1 products
Eye Shadow Primers	1 products
lip plumper	21 products
beard cleanser	3 products
other eye makeup	1 products
Preshave Preparations	2 products
foot odor control	1 products
Exfoliants	1 products
Decollete and Neck Creams	1 products
CC cream	1 products
Wipes	1 products
antiperspirant/deodorant	1 products
Tanning Sprays	2 products
Lip Stain	2 products
Facial Sun Care	1 products
nail glue	3 products

Developmental/reproductive toxicity

CONCERN	REFERENCE
One or more animal studies show reproductive effects at low doses	Evaluation of vitamin A toxicity(1990-08-01)
Known human reproductive toxicant	Talk Paper: Vitamin A and Birth Defects(1995-01-01)
Possible human reproductive or developmental toxin	European Chemicals Agency (ECHA)

Enhanced skin absorption

CONCERN	REFERENCE
Absorbs into the skin	Characterization of esterase and alcohol dehydrogenase activity in skin Metabolism of retinyl palmitate to retinol (vitamin A) during percutaneous absorption.(1994-08-01)

Organ system toxicity (non-reproductive)

CONCERN	REFERENCE
Limited evidence of skin toxicity	Unoccluded retinol penetrates human skin in vivo more effectively than unoccluded retinyl palmitate or retinoic acid(1997-09-01)
Classified as not expected to be potentially toxic or harmful	Environment Canada

Cancer

CONCERN	REFERENCE
One or more animal studies show tumor formation at very low doses	Topical retinoic acid enhances, and a dark tan protects, from subedemal solar-simulated photocarcinogenesis(2000-05-01)
One or more in vitro tests on mammalian cells show positive mutation results	Photomutagenicity of retinyl palmitate by ultraviolet a irradiation in mouse lymphoma cells(2005-11-01)
One or more in vitro tests non-mammalian cells show positive mutation results	Photo-induced DNA damage and photocytotoxicity of retinyl palmitate and its photodecomposition products(2005-09-01)
One or more animal studies show tumor formation at very low doses	NTP Draft Technical Report on the Photococarcinogenesis Study of Retinoic Acid and Retinyl Palmitate [CAS Nos 302-79-4 (All-Trans-Retinoic Acid) and 79-81-2 (All-Trans-Retinyl Palmitate)] in SKH-1 Mice (Simulated Solar Light And Topical Application Study)(2010-01-01)

Biochemical or cellular level changes

CONCERN	REFERENCE
Produces excess reactive oxygen species that can interfere with cellular signaling, cause mutations, lead to cell death and may be implicated in cardiovascular disease.	Photodecomposition of retinyl palmitate in ethanol by UVA light-formation of photodecomposition products, reactive oxygen species, and lipid peroxides(2005-02-01)
Produces excess reactive oxygen species that can interfere with cellular signaling, cause mutations, lead to cell death and may be implicated in cardiovascular disease.	UVA photoirradiation of retinyl palmitate--formation of singlet oxygen and superoxide, and their role in induction of lipid peroxidation(2006-05-05)

Use restrictions

CONCERN	REFERENCE
Violation of government restrictions - Banned or found unsafe for use in cosmetics	Vitamin A: Intake via cosmetic products should be restricted(2014-01-01)
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmetics	Health Canada

Multiple, additive exposure sources

CONCERN	REFERENCE
Designated as safe for general or specific, limited use in food	US Food and Drug Administration (FDA)

Data gaps

CONCERN	REFERENCE
Risk assessment method deficiencies and data gaps - Maximum reported 'as used' concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product	Cosmetic Ingredient Review (CIR)

Informational

CONCERN	REFERENCE
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - any	Cosmetic Ingredient Review (CIR)

Persistence and bioaccumulation

CONCERN	REFERENCE
Not suspected to be persistent	Environment Canada
Not suspected to be bioaccumulative	Environment Canada

Ecotoxicology

CONCERN	REFERENCE
Uncertain environmental toxin	Environment Canada

Evaluation of vitamin A toxicity(1990-08-01)
Talk Paper: Vitamin A and Birth Defects(1995-01-01)
European Chemicals Agency (ECHA)
Characterization of esterase and alcohol dehydrogenase activity in skin Metabolism of retinyl palmitate to retinol (vitamin A) during percutaneous absorption.(1994-08-01)
Unoccluded retinol penetrates human skin in vivo more effectively than unoccluded retinyl palmitate or retinoic acid(1997-09-01)
Environment Canada
Topical retinoic acid enhances, and a dark tan protects, from subedemal solar-simulated photocarcinogenesis(2000-05-01)
Photomutagenicity of retinyl palmitate by ultraviolet a irradiation in mouse lymphoma cells(2005-11-01)
Photo-induced DNA damage and photocytotoxicity of retinyl palmitate and its photodecomposition products(2005-09-01)
NTP Draft Technical Report on the Photococarcinogenesis Study of Retinoic Acid and Retinyl Palmitate [CAS Nos 302-79-4 (All-Trans-Retinoic Acid) and 79-81-2 (All-Trans-Retinyl Palmitate)] in SKH-1 Mice (Simulated Solar Light And Topical Application Study)(2010-01-01)
Photodecomposition of retinyl palmitate in ethanol by UVA light-formation of photodecomposition products, reactive oxygen species, and lipid peroxides(2005-02-01)
UVA photoirradiation of retinyl palmitate--formation of singlet oxygen and superoxide, and their role in induction of lipid peroxidation(2006-05-05)
Vitamin A: Intake via cosmetic products should be restricted(2014-01-01)
Health Canada
US Food and Drug Administration (FDA)
Cosmetic Ingredient Review (CIR)

Understanding scores

Cosmetics and personal care products are not required to be tested for safety before being allowed on the market. The Skin Deep® scoring system was designed to help the public understand whether a product is safe to use or whether it contains ingredients of concern.

Every product and ingredient in Skin Deep gets a two-part score – one for hazard and one for data availability. The safest products score well by both measures, with a low hazard rating and a fair or better data availability rating.

HOW WE DETERMINE SCORES

Hazard score

The Skin Deep ingredient hazard score, from 1 to 10, reflects known and suspected hazards linked to the ingredients. The EWG Verified^® mark means a product meets EWG’s strictest criteria for transparency and health.

Data availability

The Skin Deep data availability rating reflects the number of scientific studies about the product or ingredient in the published scientific literature.

NONE LIMITED FAIR GOOD ROBUST

Low Availability

Moderate Availability

High Availability