Salicylic Acid is sometimes called a beta hydroxy acid (abbreviated BHA) that can be obtained from the bark of willow trees. The salts of Salicylic Acid (Calcium Salicylate, Magnesium Salicyalte, MEA-Salicylate, Potassium Salicylate, Sodium Salicylate, TEA-Salicylate) and the esters of Salicylic Acid (Butyloctyl Salicylate, C12-15 Alkyl Salicylate, Capryolyl Salicylic Acid, Hexyldecyl Salicylate, Isocetyl Salicylate, Isodecyl Salicylate, Ethylhexyl Salicylate, Methyl Salicylate, Myristyl Salicylate, Tridecyl Salicylate) may also be used in cosmetics and personal care products.
As Salicylic Acid and its salts and esters have many functions, these ingredients may be used in many types of cosmetics and personal care products including moisturizers, skin cleansing products, shampoos, as well as skin care, hair care, suntan and sunscreen products, as well as in mouthwashes and dentifrices.
The Food and Drug Administration (FDA) has reviewed the safety of Salicylic Acid and Methyl Salicylate and permits their use as indirect food additives. Salicylic Acid is approved for use in Over-the-Counter (OTC) drug products. Salicylic acid is widely used as an FDA approved safe and effective acne drug product. It is also approved for use in OTC drugs for corn, callus and wart removal, as well as in antidandruff OTC drug products.
Ethylhexyl Salicylate and TEA-Salicylate are permitted by FDA for use as active ingredients in OTC sunscreen drug products. Ethylhexyl Salicylate may be used at concentrations up to 5%, and TEA-Salicylate may be used at concentrations up to 12%. When used in OTC sunscreen drug products in the United States, Ethylhexyl Salicylate must be called Octisalate, and TEA-Salicylate must be called Trolamine Salicylate.
The safety of Salicylic Acid and its salts and esters has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated scientific data and concluded that Salicylic Acid, Calcium Salicylate, Magnesium Salicyalte, MEA-Salicylate, Potassium Salicylate, Sodium Salicylate, TEA-Salicylate, Butyloctyl Salicylate, C12-15 Alkyl Salicylate, Capryolyl Salicylic Acid, Hexyldecyl Salicylate, Isocetyl Salicylate, Isodecyl Salicylate, Ethylhexyl Salicylate, Methyl Salicylate, Myristyl Salicylate and Tridecyl Salicylate were safe as used when formulated to avoid skin irritation and when formulated to avoid increasing the skin's sun sensitivity, or, when increased sun sensitivity would be expected, directions for use include the daily use of sun protection.CIR Safety Review: In reaching its conclusion, the CIR Expert Panel considered three primary issues: (1) increased sun sensitivity (e.g., UV radiation induced skin damage); (2) skin irritation; and (
The CIR Expert Panel took into account application as exfoliating agents in cosmetic formulations at concentrations of use at the high end of reported use levels, in addition to the other uses that have been specified. The CIR Expert Panel noted that repeated use of Salicylic Acid and the various salicylates may effectively increase exposure of the dermis and epidermis to UV radiation. However, information is available suggesting that these ingredients absorb UV radiation, which would decrease the exposure.
Drawing on its previous experience in reviewing the safety of alpha hydroxy acids (AHAs), the CIR Expert Panel compared the relatively mild exfoliating action of Salicylic Acid and the various salicylates with that of AHAs, factored in the ultraviolet radiation absorption by salicylates, and estimated that the potenital increase in sun sensitivity associated with use of AHAs would likely be smaller with salicylates.
The CIR Expert Panel was concerned that exfolient action would increase the possibility that some increase in UV radiation-induced skin damage would be detected. Therefore, the CIR Expert Panel advised the cosmetics industry that there can be a risk of increased UV radiation damage with the use of any exfoliant, and that steps need to be taken to formulate cosmetic products with these ingredients so as not to increase sun sensitivity, or when increased sun sensitivity would be expected, to include directions for the daily use of sun protection.
The CIR Expert Panel noted that clinical safety test data demonstrated that these ingredients are generally milder than AHAs and the CIR Expert Panel concluded that it is possible to formulate cosmetic and personal care products in a way such that significant irritation would not occur.
Reproductive and developmental toxicity associated with exposures to large, therapeutic serum concentrations of Salicylic Acid (as a metabolite of aspirin) have been extensively demonstrated. The CIR Expert Panel concluded that topical use of Salicylic Acid or the various salicylates would not produce serum levels of Salicylic Acid that would result in a reproductive or developmental toxicity risk.
A study initiated by the FDA and conducted by the National Toxicology Program (NTP) was designed to determine if Salicylic Acid increases the risk of UV light induced skin tumors. Although the strain of mice used in this study was very sensitive to developing skin tumors when exposued to UV light, Salicylic Acid did not increase skin tumors.
Link to information about this NTP study:
http://ntp.niehs.nih.gov/index.cfm?objectid=BDC08D46-123F-79...
Link to the FDA Code of Federal Regulations for Salicylic Acid, Sodium Salicylate, Methyl Salicylate, and Octyl (Ethylhexyl) Salicylate
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Salicylic Acid it salts are listed in the Cosmetics Directive of the European Union and may be used as preservatives in cosmetics and personal care products at a maximum concentration of 0.5% (see Annex VI).
In Europe, for uses other than as a preservative, Salicylic Acid may be used in rinse-off hair products at concentrations up to
Ethylhexyl Salicylate is listed in the Cosmetics Directive of the European Union and may be used as a UV filter at a concentration up to 5% (see Annex VII).
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
Health Canada permits the use of Salicylic Acid in cosmetics and personal care products in concentrations equal to or less than 2%.
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/hotlist-liste_3...
Ethylhexyl Salicylate (up to 6%) and TEA-Salicylate (up to 12%) are permitted for use in sunscreen products in Canada.
