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

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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Clinical Report: FDA Permits New Sunscreen Ingredient After 20 Years

Overview

The FDA has added bemotrizinol to the OTC sunscreen monograph, marking the first new active ingredient since the late 1990s. Bemotrizinol offers protection against UVA and UVB radiation and is recognized as safe and effective for adults and children aged 6 months and older.

Background

The addition of bemotrizinol is significant as skin cancer rates continue to rise. The FDA's action reflects ongoing efforts to enhance consumer safety and efficacy in sunscreen formulations.

Data Highlights

No numerical data provided in the source material.

Key Findings

  • Bemotrizinol is the first new sunscreen active ingredient added to the OTC monograph since the late 1990s.
  • It provides protection against both UVA and UVB radiation.
  • The ingredient has low systemic absorption following topical use.
  • Bemotrizinol is recognized as generally safe and effective for use in sunscreen products for adults and children aged 6 months and older.
  • The FDA's approval process for bemotrizinol was expedited under the Coronavirus Aid, Relief, and Economic Security Act.

Clinical Implications

Healthcare professionals should be aware of the new sunscreen options available, including those containing bemotrizinol.

Conclusion

The FDA's addition of bemotrizinol to the OTC sunscreen monograph represents a significant advancement.

Related Resources & Content

  1. FDA, FDA, 2026 -- FDA Expands Sunscreen Options for the First Time in 20 Years
  2. American Academy of Dermatology, AAD, 2026 -- American Academy of Dermatology Statement on the Importance of Sun Protection
  3. Journal of Clinical Oncology, 2010 -- Reduced Melanoma After Regular Sunscreen Use: Randomized Trial Follow-Up
  4. The ASCO Post — FDA Commissioner Margaret A. Hamburg’s Statement on the Surgeon General’s Call to Action to Prevent Skin Cancer
  5. The ASCO Post — Capitalizing on Increased Interest in Skin Cancer During Summer to Reeducate People About Sunscreens and ‘Smart Sun Strategies’
  6. Contact Lens Spectrum — FDA Accepts NDA for Tenpoint's Brimochol PF
  7. Optometric Management — Practice Pulse: Tips, Trends & New You Can Use
  8. FDA Commissioner Margaret A. Hamburg’s Statement on the Surgeon General’s Call to Action to Prevent Skin Cancer
  9. Capitalizing on Increased Interest in Skin Cancer During Summer to Reeducate People About Sunscreens and ‘Smart Sun Strategies’
  10. FDA Accepts NDA for Tenpoint's Brimochol PF
  11. FDA Expands Sunscreen Options for the First Time in 20 Years | FDA
  12. American Academy of Dermatology Statement on the Importance of Sun Protection
  13. Reduced Melanoma After Regular Sunscreen Use: Randomized Trial Follow-Up | Journal of Clinical Oncology

Original Source(s)

FDA Permits New Sunscreen Ingredient After 20 Years

  • by Kathryn Wighton

  • June 9, 2026

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