FDA Permits New Sunscreen Ingredient After 20 Years - Takeaways - MDSpire

FDA Permits New Sunscreen Ingredient After 20 Years

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  • Kathryn Wighton

  • June 9, 2026

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  • 1

    The FDA has added bemotrizinol to the OTC sunscreen monograph, marking the first new active ingredient since the late 1990s.

  • 2

    Bemotrizinol offers protection against both UVA and UVB radiation and has low systemic absorption when used topically.

  • 3

    The FDA considers bemotrizinol generally recognized as safe and effective for adults and children aged 6 months and older.

  • 4

    The ingredient can be used in OTC sunscreen products that comply with monograph requirements, but does not approve specific products.

  • 5

    Bemotrizinol was previously marketed in Europe and other countries before its authorization in the U.S. under a streamlined process.

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