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

This article was originally published in The Rose Sheet

Executive Summary

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, see chart, p. 18).

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