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

The sunscreen ingredient, which has been marketed internationally for years, is considered generally recognized as safe and effective for use in adults and pediatric patients aged 6 months and older.

  • By

  • Kathryn Wighton

  • June 9, 2026

  • 2 min

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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.

Original Source(s)

FDA Permits New Sunscreen Ingredient After 20 Years

  • by Kathryn Wighton

  • June 9, 2026

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