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On 11 September 2026, the US Food and Drug Administration (FDA) issued a final administrative order to amend the requirements for sunscreen products under the Over-The-Counter (OTC) Sunscreen Monograph. The order removes aminobenzoic acid (PABA) and trolamine salicylate from the sunscreen active ingredients permitted under OTC Monograph M020 and will take effect on 11 September 2027.
The decision finalises part of the FDA's 2021 proposed order, in which the FDA proposed that PABA and trolamine salicylate should not be considered Generally Recognised as Safe and Effective (GRASE) for use as sunscreen active ingredients. Following its review of the available safety data, FDA concluded that the risks associated with their use outweigh their benefits.
Once the final order is in effect, sunscreen drug products containing PABA or trolamine salicylate cannot be marketed under the sunscreen OTC monograph and can no longer be sold without FDA approval. FDA has stated that it is not aware of any sunscreen drug products containing either ingredient currently being marketed in the US.
More information can be found on the FDA website.
