Legis Daily

SAFE Sunscreen Standards Act

USA119th CongressS-2491| Senate 
| Updated: 7/29/2025
Margaret Wood Hassan

Margaret Wood Hassan

Democratic Senator

New Hampshire

Cosponsors (1)
Roger Marshall (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The "Supporting Accessible, Flexible, and Effective Sunscreen Standards" or "SAFE Sunscreen Standards Act" aims to modernize the regulatory review process for nonprescription drugs intended for topical administration , particularly sunscreen active ingredients. It amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to utilize standards that incorporate real-world evidence when evaluating the generally recognized as safe and effective (GRASE) status of these ingredients, supplementing traditional clinical trials. The bill also mandates the consideration of non-animal testing methods for topical active ingredients and requires guidance on their use within one year. Crucially, it directs that the final administrative order on nonprescription sunscreen active ingredients must account for historical data , acknowledge the role of broad-spectrum sunscreens with SPF 15 or higher in skin cancer prevention, and integrate the new evidence and testing standards. To ensure transparency, the Act requires the Secretary to submit annual reports to Congress for five years, detailing the implementation of these standards and progress in adopting nonclinical testing alternatives, with all reports published online.
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Timeline
Jun 3, 2025

Latest Companion Bill Action

HR 119-3686
Introduced in House
Jul 29, 2025
Introduced in Senate
Jul 29, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • June 3, 2025

    Latest Companion Bill Action

    HR 119-3686
    Introduced in House


  • July 29, 2025
    Introduced in Senate


  • July 29, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

SAFE Sunscreen Standards Act

USA119th CongressS-2491| Senate 
| Updated: 7/29/2025
The "Supporting Accessible, Flexible, and Effective Sunscreen Standards" or "SAFE Sunscreen Standards Act" aims to modernize the regulatory review process for nonprescription drugs intended for topical administration , particularly sunscreen active ingredients. It amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to utilize standards that incorporate real-world evidence when evaluating the generally recognized as safe and effective (GRASE) status of these ingredients, supplementing traditional clinical trials. The bill also mandates the consideration of non-animal testing methods for topical active ingredients and requires guidance on their use within one year. Crucially, it directs that the final administrative order on nonprescription sunscreen active ingredients must account for historical data , acknowledge the role of broad-spectrum sunscreens with SPF 15 or higher in skin cancer prevention, and integrate the new evidence and testing standards. To ensure transparency, the Act requires the Secretary to submit annual reports to Congress for five years, detailing the implementation of these standards and progress in adopting nonclinical testing alternatives, with all reports published online.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jun 3, 2025

Latest Companion Bill Action

HR 119-3686
Introduced in House
Jul 29, 2025
Introduced in Senate
Jul 29, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • June 3, 2025

    Latest Companion Bill Action

    HR 119-3686
    Introduced in House


  • July 29, 2025
    Introduced in Senate


  • July 29, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Margaret Wood Hassan

Margaret Wood Hassan

Democratic Senator

New Hampshire

Cosponsors (1)
Roger Marshall (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted