Summary

Directs the FDA to modernize how it evaluates sunscreen active ingredients by establishing updated safety and effectiveness standards, formally accepting non-animal testing alternatives, and permitting real-world evidence and observational studies in place of or alongside traditional clinical testing. Requires FDA to issue guidance within 180 days, to fold the new standards into the pending OTC sunscreen active ingredient administrative order, and to report annually to Congress on implementation and use of nonclinical alternative tests.

• Directs FDA to set modern safety and efficacy standards for sunscreen active ingredients.
• Requires FDA to permit and provide guidance on non-animal testing alternatives within 180 days.
• Allows use of real-world evidence and observational studies alongside or instead of traditional clinical trials.
• Applies existing prima facie safe nonprescription marketing/use rule to sunscreen active ingredients.
• Requires the final administrative order on pending OTC sunscreen submissions to incorporate the new standards and historical safety data.
• Mandates annual reports to Congress on implementation and progress, published to FDA’s website within 7 days.
• Does not appropriate funds or create new spending streams; focuses on regulatory and evidentiary standards.
• Intended to speed and broaden pathways for new sunscreen active ingredient evaluation while reducing animal testing.