HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

You may also be interested in...



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

Related Content

UsernamePublicRestriction

Register

RS012429

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel