FDA Removes Two Old Filters From Over-the-Counter Sunscreens

FDA has finalised the removal. On 11 September 2026 the agency published notice of final administrative order OTC000008-1, striking PABAAminobenzoic AcidLimitedPABA · Organic UV filter (aminobenzoate)Legacy sunscreen filter FDA has determined is not GRASE; removed from OTC Monograph M020 by final order OTC000008-1.Open in the Index → and trolamine SalicylateTrolamine SalicylateLimitedTrolamine Salicylate · Organic UV filter (salicylate salt)Legacy sunscreen active FDA has determined is not GRASE; removed from OTC Monograph M020 alongside PABA.Open in the Index → from OTC Monograph M020. Products with either active are not GRASE as OTC sunscreens under the amended monograph[1].

In practice this is housekeeping: neither filter has been common in US sun care for years, but the order formally closes the monograph pathway to them. FDA says it is unaware of currently marketed U.S. sunscreens still using them; once the order’s effective date lands, residual SKUs cannot ride the monograph pathway without a separate approval[1].

Read it next to the bemotrizinol add: one filter in, two legacy names out. The monograph is moving, slowly, toward a shorter and clearer active list[1].