The U.S. Food and Drug Administration (FDA) approved TEA-salicylate (trolamine salicylate) for use as an active sunscreen ingredient in over-the-counter (OTC) sunscreen drug products at concentrations up to 12 percent. In 2019, FDA issued a new Proposed Rule for Sunscreen Drug Products for Over-the-Counter Human Use describing the conditions under which it proposed OTC sunscreen products are generally recognized as safe and effective (GRASE) and not misbranded. The 2019 proposed rule concluded the risks associated with use of trolamine salicylate in sunscreen products outweighs its benefits. Accordingly, FDA proposed trolamine salicylate be classified as a Category II (i.e., not GRASE) sunscreen active ingredient, due to safety concerns. If this proposed rule becomes final, sunscreen products in the marketplace would no longer be allowed to contain trolamine salicylate as an active ingredient. FDA’s Preliminary Regulatory Impact Analysis reviewed more than 700 sunscreen brands sold in the United States, and indicated trolamine salicylate is no longer used in products marketed in the U.S.
2019 FDA Proposed Rule
Trolamine salicylate is comprised of trolamine and salicylic acid. FDA was concerned that use of trolamine salicylate as an active ingredient in sunscreens could cause serious detrimental health effects due to the anti-coagulation effects of salicylic acid. FDA located two case reports of serious coagulation-related adverse events associated with liberal dermal application of trolamine salicylate.
FDA was also concerned sunscreens containing trolamine salicylate could lead to other adverse effects associated with salicylic acid exposure, including gastrointestinal distress and hemorrhage. At high doses, acute salicylate toxicity (salicylism) may occur.
FDA considered the safety concerns associated with trolamine salicylate significant enough to place trolamine salicylate in Category II and recently proposed that trolamine salicylate is not GRASE for use in sunscreens.
Expert Panel for Cosmetic Ingredient Safety
The safety of salicylic acid and its salts and esters, including TEA-salicylate, has been assessed by the Expert Panel for Cosmetic Ingredient Safety on several occasions. However, per Expert Panel standard procedure, the use of TEA-salicylate as a sunscreen ingredient was not included in the review (the Expert Panel does not review the active ingredients in over-the-counter drugs). Therefore, the review of this ingredient was limited to its use in product protection. In 2003, the Panel evaluated scientific data and concluded TEA-salicylate and the other salicylates were safe as used when formulated to avoid skin irritation; 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.
In accordance with its Procedures, the Expert Panel re-evaluates the conclusions of previously-issued reports every 15 years. In 2019, the Panel conducted its re-evaluation. Based on an evaluation of all available scientific data, the Expert Panel concluded salicylic acid and 17 salicylate ingredients (including TEA-salicylate/ trolamine salicylate) are safe in cosmetics in the present practices of use and concentration, when formulated to be non-irritating and non-sensitizing to skin, which may be based on a quantitative risk assessment (QRA). This conclusion superseded the 2003 conclusion. As before, the review of TEA-salicylate did not include its use as an active sunscreen ingredient.
Salicylic acid and its salts (including TEA-salicylate) 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 percent (see Annex V, entry 3). TEA-salicylate may be used in rinse-off cosmetic products without concentration restrictions and in leave-on products at a maximum concentration of 2.5 percent (see Annex III, entry 62). Salicylic acid and its salts should not be used in products for children under 3 years of age, except for shampoo formulations. TEA-salicylate is not approved as an active sunscreen ingredient in the EU.
TEA-Salicylate (up to 12 percent) is permitted for use in sunscreen products in Canada.