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On 10 June 2026, the US Food and Drug Administration (FDA) issued a final order to amend the requirements for sunscreen drug products under the Over-The-Counter (OTC) Sunscreen Monograph. This final order amends OTC Monograph M020 to add bemotrizinol as a sunscreen active ingredient and takes effect on 9 August 2026.
This is the first new sunscreen active ingredient to be added to the US OTC Sunscreen Monograph in over 20 years. Bemotrizinol provides broad-spectrum protection against UVA and UVB rays and has already been used for a number of years in Europe, Australia and some Asian markets.
The FDA considers bemotrizinol to be Generally Recognised as Safe and Effective (GRASE) for use in sunscreens by adults and children aged six months and older, at concentrations up to 6%.
More information can be found on the FDA website.
