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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 ester 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 antioxidant helping to protect the skin from the signs of premature aging caused by exposure to the sun.
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.
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.
The safety of retinol and retinyl palmitate has been assessed on several occasions by the Cosmetic Ingredient Review (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.
The Food and Drug Administration (FDA) includes both ingredients on its list of substances affirmed as Generally Recognized As Safe (GRAS) 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 65 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 Union .
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:
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).
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