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FDA Proposes New Rule for Sunscreen Products

Posted: September 19, 2007

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When finalized, the regulation would amend the existing OTC sunscreen rule published in 1999. It will also revise the existing SPF (UVB) testing procedures, allow new combinations of active ingredients and ask for comments of the issue of nanoparticles.

Comments of the new rule will be accepted until November 26, 2007. These must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form.

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Fax: 301-827-6870

Electronic submissions can be made at: www.regulations.gov or www.fda.gov/dockets/ecomments.