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.