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High SPF "Uses" Statement Addresses FDA Concerns - CTFA

This article was originally published in The Tan Sheet

Executive Summary

Sunscreens with SPF values over 30 should carry a mandatory labeling statement that advises consumers against extending the length of time spent in the sun while noting the benefits of additional sun protection, the Cosmetic Toiletry & Fragrance Association says in comments recently made available by FDA.

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Additional High SPF Sunscreen Data Sought By FDA

FDA expects to publish a "comprehensive" sunscreen final monograph covering formulation, labeling and testing methodologies for both UVA and UVB radiation by Dec. 31, 2001, the agency announces in a June 8 Federal Register notice.

High-SPF Test Standards Possible Following Modifications - FDA

FDA may consider a standardized sunscreen testing method for higher-SPF products if sufficient additional information is provided and found acceptable, the agency said at a working group meeting with industry in Rockville, Md. Oct. 26.

"SPF 30 Plus" Term Required For High-Protection Sunscreens - FDA Final Reg

Sunscreens containing an SPF over 30 will be required to use one collective term, "SPF 30 plus" or "SPF 30+" on labeling under FDA's final sunscreen monograph published in the Federal Register May 21. Due to the projected considerable economic burden on sunscreen manufacturers to comply with the regulation, FDA is extending the proposed 12-month compliance deadline to 24 months (for other provisions of the reg, see chart, p. 6).

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