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FDA’s Proposed Sunscreen Rule Could Bring SPFs Back Down To Earth, Deter SPF Fraud Suits

 
• By Ryan Nelson

SPF claims would be capped at SPF 60+ under FDA’s proposed rule, and companies would be required to label products using the lowest SPF measured in testing and maintain test records that would be accessible to FDA during inspections. The proposal also includes new broad-spectrum requirements, among a host of other changes.

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FDA would require most sunscreen products to provide broad-spectrum defense with UVA protection proportionate to UVB, while promoting more reliable SPF claims and limiting them to SPF 60+, under a proposed sunscreen rule released Feb. 21.

The proposed rule would establish a final monograph for OTC sunscreen drug products, defining conditions under which they would...

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