THE WHAT? The US Food and Drug Administration (FDA) has proposed adding bemotrizinol to the OTC sunscreen monograph, opening the door for its use as a permitted active ingredient in US sunscreens.
THE DETAILS Under a proposed administrative order, the FDA would allow bemotrizinol at concentrations of up to 6% as a generally recognized as safe and effective (GRASE) sunscreen active for adults and children aged six months and older. The ingredient provides broad-spectrum UVA and UVB protection and has been assessed by the agency as having low skin absorption and a low incidence of irritation.
The proposal follows an OTC Monograph Order Request (OMOR) submitted by DSM Nutritional Products LLC. While bemotrizinol is widely used in sunscreens outside the US, it has not previously been permitted under the FDA’s sunscreen monograph.
The FDA is now seeking public comment. If finalized, bemotrizinol would be added to OTC Monograph M020, allowing products meeting monograph conditions to enter the market without individual drug approvals.
THE WHY? Expanding the US sunscreen filter list would help close the innovation gap between the US and international markets, giving formulators access to modern UV filters already standard elsewhere.
Source: FDA
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