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119-s-2491119th CongressWALLET

SAFE Sunscreen Standards Act

Sponsored By: Senator Hassan, Margaret Wood [D-NH]

Introduced

Summary

Modernizing how the FDA evaluates and tests active ingredients in topical over-the-counter drugs. This bill would require the agency to weigh benefits against risks using traditional clinical data plus real-world evidence, accept appropriate non-animal tests, and set clearer sunscreen standards.

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  • Families and consumers: Would ensure final sunscreen rules account for historical safety data and recognize the skin cancer prevention role of broad-spectrum sunscreens with SPF 15 or higher.
  • Drug sponsors and manufacturers: Would allow sponsors to use real-world evidence and specific nonclinical testing alternatives to meet safety and effectiveness standards. The FDA would have to issue draft guidance on using non-animal methods within 1 year.
  • FDA oversight and transparency: Would require a report to relevant congressional committees 18 months after enactment and annually for five years on implementation, the number of sunscreen ingredient reviews, and progress toward non-animal testing. Reports would be posted on FDA's website within 7 days.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 1 benefits, 0 costs, 1 mixed.

Sunscreen orders must consider safety

If enacted, the FDA would have to make any final administrative order on over-the-counter sunscreen ingredients account for past U.S. safety data. The agency would have to recognize the role of broad-spectrum sunscreens with SPF 15 or higher in preventing skin cancer and use the bill's evidence and testing standards for sunscreen actives.

New testing rules for topical drugs

If enacted, the FDA would be allowed to use real-world evidence to supplement clinical trials when reviewing active ingredients in over-the-counter topical drugs. The agency would have to weigh benefits against risks and apply testing standards to topical ingredients. The FDA would also have to consider certain non-animal lab tests and publish draft guidance on using those alternatives within one year of enactment.

Sponsors & CoSponsors

Sponsor

Hassan, Margaret Wood [D-NH]

NH • D

Cosponsors

  • Sen. Marshall, Roger [R-KS]

    KS • R

    Sponsored 7/29/2025

Roll Call Votes

No roll call votes available for this bill.

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