Current status of the sunscreen regulation in the United States: 2011 Food and Drug Administration's final rule on labeling and effectiveness testing.

ANPR: Advance Notice of Proposed Rulemaking CW: critical wavelength FDA: Food and Drug Administration MED: minimal erythema dose PPD: persistent pigment darkening SPF: sun protection factor TEA: Time and Extent Application INTRODUCTION On June 17, 2011, the US Food and Drug Administration (FDA) issued its long awaited final ruling on labeling and effectiveness testing of sunscreen products in the United States. At the same time, the FDA published 3 other documents: (1) a Draft Enforcement Guidance for Industry document, further explaining the final rule, (2) a Proposed Rule on sunscreens with sun protection factors (SPFs) greater than 50, seeking additional comments on its proposal to cap SPF at 501, and (3) an Advance Notice of Proposed Rulemaking (ANPR), requesting information about alternative dosage forms of sunscreen products (ie, sprays), and proposing that certain dosage forms (wipes, towelettes, powders, body washes, and shampoos) to be considered not eligible for review under the sunscreen monograph process. Only the final rule regarding labeling and testing of sunscreens has been approved, whereas the regulations and suggestions in the other 3 documents, hence the sunscreen monograph itself, have not been finalized. This announcement signals a recognition by the FDA of the clinical benefits of photoprotection, with sunscreens as one of the measures. Furthermore, it provides a much anticipated standard for testing and labeling UVA protection in sunscreens.