FDA Proposes New Sunscreen Rules

Posted: August 24, 2007

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"Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens," said Douglas Throckmorton, MD, deputy director of FDA's Center for Drug Evaluation and Research, in a press statement. "The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen."

Once finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a SPF. The FDA also is reportedly amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF2 to SPF50+. SPF50 provides more UVB protection than lower SPF values.

Additionally, the proposed rule: revises the existing SPF (UVB) testing procedures; allows new combinations of active ingredients; and asks for comments on the issue of nanoparticles. FDA is accepting comments on the new rule for 90 days until November 26, 2007. Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at the following Web sites: Federal eRulemaking Portal: www.regulations.gov ; FDA Web site: www.fda.gov/dockets/ecomments;  Written submissions can be submitted by fax or mail: Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852; Fax: 1-301-827-6870.