Retinyl Palmitate
What Is It?
Retinol is the primary naturally occurring form of vitamin A. It is a pale yellow crystalline material or a thick liquid. Retinyl palmitate is the esterAn organic compound formed by the reaction of an acid with an alcohol. of retinol and palmitic acid and is a yellow to yellow-red solid or oily substance. In cosmetics and personal care products, these ingredients are used primarily in the formulation of hair, facial makeup and skin care products. When used in sunscreens, it is not an active drug ingredient, but rather a cosmetic ingredient that acts as an antioxidantIngredients that prevent or slow deterioration due to chemical reaction with oxygen. helping to protect the skin from the signs of premature aging caused by exposure to the sun.
Why Is It Used?
Retinol and retinyl palmitate (RP) enhance the appearance of dry or damaged skin by reducing flaking and restoring suppleness. RP is sometimes added to sunscreen products as an antioxidant that helps reduce the signs of skin aging caused by exposure to sunlight. It is the major storage form of vitamin A found naturally in our skin. It should be noted that it is not an FDA-approved sunscreen active ingredient and does not replace the need for an approved sunscreen.These ingredients are also used as hair conditioning agents that enhance the appearance and feel of hair, by increasing hair body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment.
Scientific Facts
Retinol and retinyl palmitate are produced by commercial methods but can be found naturally in animal fats, in fish liver oil, and in plants that contain beta-carotene, a vitamin A precursor. Retinol is essential for vision, growth, and reproduction. Retinyl palmitate is produced from Retinol and is sometimes referred to as vitamin A palmitate when used as a nutrient or drug. In addition to their use in cosmetics and personal care products, both ingredients can be found in foods and in vitamin supplements.
Safety Information
United States
CIR
The safety of retinol and retinyl palmitate has been assessed on several occasions by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The Expert Panel evaluated available scientific data in 1987 and concluded that they were safe as cosmetic ingredients. In 2005, the Expert Panel considered available new data and reaffirmed the above conclusion. Once again, in 2013, the CIR Expert Panel looked at additional new data and decided the data were not sufficient to re-open the safety assessment. The ‘safe as used’ conclusion in previous reports was confirmed.
FDA
The Food and Drug Administration (FDA) includes both ingredients on its list of substances affirmed as Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.) for direct addition to food. Their functional use in foods are as nutrients and dietary supplements.
The FDA has also approved these ingredients for several Over-the-Counter (OTC) drug uses.
State of California
The state of California lists retinol and retinyl esters, including retinyl palmitate, as Proposition 65Proposition 65 is a California citizens initiative that was enacted as “The Safe Drinking Water and Toxic Enforcement Act of 1986.” Proposition 65 requires the State to publish a list of chemicals known to the state of California to cause cancer or birth defects or other reproductive harm. Businesses are then required to notify Californians about these chemicals if they are present in the products they purchase, in their homes or workplaces, or that are released into the environment. chemicals “known to the state” to cause reproductive toxicity at daily dosages in excess of 10,000 IU. It is noted that retinol/retinyl esters are required and essential for maintenance of normal reproductive function, and the recommended daily level during pregnancy is 8,000 IU.
Cosmetics and personal care products do not contain large amounts of these ingredients and a scientific research study showed that, even when very high concentrations (much larger than those used in products) were applied to the skin, they did not substantially contribute to the amount of vitamin A naturally occurring in the blood. Therefore, cosmetics and personal care products containing these ingredients do not need to be labeled with a Proposition 65 warning.
European Union (EU)
Retinyl palmitate and retinol may be used without restrictions in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions. .
Canada
Health Canada permits the use of retinyl palmitate and retinol in cosmetics and personal care products at concentrations equal to or less than 1%.
Myth: Some reports in the media have suggested that the use of retinyl palmitate in sunscreens may cause skin cancer. Is this true?
The Facts: Reports that retinyl palmitate could increase skin cancer risks are false. No published studies show that its use in sunscreens is toxic to humans or hazardous to human health. Scientific studies support the safety of using sunscreens.
When used in sunscreens, it is not an active drug ingredient, but rather a cosmetic ingredient that acts as an antioxidant helping to protect the skin from the signs of premature aging caused by exposure to the sun. The American Academy of Dermatology (AAD) notes that decades of clinical experience with the use of this ingredient do not support the notion that its use in sunscreen causes or promotes skin cancer. The AAD states the following facts about retinyl palmitate:
- No study shows that it increases the risk of skin cancer in humans.
- It is a form of vitamin A that is found naturally in the skin.
- One form of vitamin A, retinoids, has been used for decades to prevent skin cancer in people who have a high risk of developing skin cancers.
This ingredient is also approved by the Food and Drug Administration (FDA) as safe for use in over-the-counter (OTC) and prescription drugs, and it is also approved as safe for use as a food additive (e.g., to fortify low-fat milk, dairy products and breakfast cereals with vitamin A).
Resources
Find out more about the regulation of Food Additives by the Food and Drug Administration
Food Ingredients and Packaging
Substances Generally Recognized As Safe (GRAS)
Search the Code of Federal Regulations