Sunscreen Drug Facts Implementation Delayed To Coincide With FM
This article was originally published in The Rose Sheet
Executive Summary
FDA has indefinitely delayed the May 16, 2005 implementation date of the drug facts labeling final rule for OTC sunscreen products to avoid dual relabeling that could be required after the stay of the sunscreen final monograph is lifted, the agency announced in the Sept. 3 1Federal Register
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Sunscreen labeling
Sun care manufacturers will need "sufficient" time to comply with labeling requirements under the OTC drug facts final rule, the Cosmetic, Toiletry and Fragrance Association notes in comments submitted to FDA Dec. 2. "The process of reformatting and redesigning labels to implement requirements of the drug facts rule as it applies to OTC sunscreen drug products will be a lengthy undertaking," the association adds, noting its support for the delayed implementtation. FDA requested comments from stakeholders on its decision to postpone the May 16, 2005 implementation date of the drug facts for OTC sunscreen drug products in Sept. 3 Federal Register notice (1"The Rose Sheet" Sept. 6, 2004, p. 5)...
Sunscreen labeling
Sun care manufacturers will need "sufficient" time to comply with labeling requirements under the OTC drug facts final rule, the Cosmetic, Toiletry and Fragrance Association notes in comments submitted to FDA Dec. 2. "The process of reformatting and redesigning labels to implement requirements of the drug facts rule as it applies to OTC sunscreen drug products will be a lengthy undertaking," the association adds, noting its support for the delayed implementtation. FDA requested comments from stakeholders on its decision to postpone the May 16, 2005 implementation date of the drug facts for OTC sunscreen drug products in Sept. 3 Federal Register notice (1"The Rose Sheet" Sept. 6, 2004, p. 5)...
Sunscreen Monograph Effective Date Extended To Address UVA Standards
The Dec. 31, 2002 implementation date of the OTC sunscreen final monograph has been postponed until further notice for the majority of sunscreens, the agency announces in a 11Dec. 31 Federal Register notice