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FDA Proposes New Rule for Sunscreen Products

The U.S. Food and Drug Administration (FDA) recently proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

Because sunlight is composed of both UVA and UVB rays, the organization proposes the creation of a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product, instead of only the level of UVB protection identified through SPF values.

The proposed four-star ratings system works with one star representing low UVA protection, two stars, medium; three stars, high; and four stars the highest UVA protection available in an OTC sunscreen product. If it doesn't provide at least a one-star protection rating, the FDA is proposing to require the product to bear a "no UVA protection" marking on the front label near the SPF value.

These ratings would be derived from two tests to assess the UVA deflection effectiveness. The first measures a product's ability to reduce the amount of UVA radiation that passes through it. The second measures its ability to prevent tanning.

Also, a "Warnings" statement in the Drug Facts box will be required from all sunscreen manufacturers that will say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using sunscreen."

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: or