U.S. Sunscreen Monograph Updates

FDA Removing Aminobenzoic Acid (PABA) and Trolamine Salicylate from Sunscreen Monograph (September 11, 2026)

In 2021, the FDA proposed amending the Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use to remove PABA and Trolamine salicylate as sunscreen active ingredients because they found “that the risks associated with use of these active ingredients in sunscreen drug products outweigh their benefits”.

The only comments that the FDA received after the proposal agreed with the updates. So, unless otherwise disputed, the new final administrative order removing PABA and Trolamine salicylate from the monograph shall take effect on September 11, 2027.

Note: The FDA stated in a Q&A that they are still working on other sunscreen provisions from the 2021 proposal including labeling, dosage forms, and maximum SPF levels.

Link: https://www.federalregister.gov/documents/2026/09/11/2026-18551/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use-and

Sunscreen Monograph Amendment Reminder – Bemotrizinol and Spray Sunscreens (August 9, 2026)

The sunscreen monograph updates to add the active ingredient Bemotrizinol and update the spray dosage form requirements took effect August 9. The following changes are now in effect:

• Bemotrizinol is permitted in sunscreens up to 6%
  • Note: There is an 18-month exclusivity period following the effective date
• Spray sunscreens with Bemotrizinol shall be manufactured and packaged:
  • With no propellant or
  • In a spray delivery system where all propellants are isolated from the drug product formulation within the container closure system and there is no contact between propellant and the drug product formulation.

Link: https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf

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