The U.S. Food and Drug Administration (FDA) approved PABA for use as a sunscreen active ingredient in Over-the-Counter (OTC) sunscreen drug products at concentrations up to 15 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 PABA in sunscreen products outweighs its benefits. Accordingly, FDA proposed PABA 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 PABA as an active ingredient. FDA’s Preliminary Regulatory Impact Analysis reviewed more than 700 sunscreen brands sold in the United States, and indicated PABA is no longer used in products marketed in the U.S.
2019 FDA Proposed Sunscreen Rule
FDA concluded in its evaluation of the available safety data for para-aminobenzoic acid (PABA) the risks associated with its use in sunscreen products outweighs its benefits. The risks include significant rates of allergic and photoallergic skin reactions, as well as cross-sensitization with structurally similar compounds.
The clinical information available to FDA included significant numbers of reports of allergic and photoallergic skin reactions to PABA, with rates of PABA-induced skin reactions potentially 8 percent or higher. FDA considered this incidence a serious concern. By comparison, only 34 hypersensitivity reactions associated with sunscreen products had been identified in FDA’s adverse event reporting system (FAERS) since 1969.
FDA considered these safety concerns associated with PABA significant enough to place PABA in Category II. Therefore, FDA proposed that PABA is not generally recognized as safe and effective (GRASE) for use in sunscreens.
Expert Panel for Cosmetic Ingredient Safety
The Expert Panel for Cosmetic Ingredient Safety deferred evaluation of this ingredient because, in accordance with the provisions of Expert Panel procedures, over-the-counter drugs are not assessed.
PABA is listed in the EU’s Annex II (list of substances prohibited in cosmetic products).
PABA is listed on Canada’s Cosmetic Ingredient Hotlist as a substance prohibited in cosmetic products.