FDA proposal would add UVA-protection rating to sunscreen labels

September 1, 2007

Washington - The Food and Drug Administration (FDA) has announced proposed changes in regulations governing formulation, testing and labeling of over-the-counter sunscreen products claiming to offer protection from ultraviolet A and ultraviolet B radiation.

Key Points

National report - The Food and Drug Administration (FDA) has announced proposed changes in regulations governing formulation, testing and labeling of over-the-counter (OTC) sunscreen products claiming to offer protection from UVA and UVB radiation.

The changes would mean consumers could determine the level of UVA protection from product labels. Under current regulations, only UVB protection levels are indicated, as Sunburn Protection Factor (SPF) values.

Also, the changes would increase the maximum allowable SPF rating, revise existing SPF testing procedures and allow new combinations of active ingredients to be used in sunscreens.

If a sunscreen does not offer at least a "one star" UVA-protection rating, the label would include the words "No UVA Protection."

To determine the UVA ratings, the FDA proposes that companies perform two tests - a lab test and a test on live subjects - to evaluate a product's UVA-protection level. The lowest-rated of the two tests would determine the star rating to appear on the label.

The proposed changes also would require a warning statement to appear in the label's "Drug Facts" box: "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 a sunscreen."

The new regulation also would recognize SPF values up to SPF50+. The current maximum allowed is SPF30+.

American Academy of Dermatology President Diane R. Baker, M.D., says the academy has long lobbied for such changes.

"The academy strongly supports the FDA's ongoing efforts to provide current and useful information to help the public make knowledgeable decisions about protecting themselves from the dangers of the sun," she said in a prepared statement.

Boston dermatologist Ranella Hirsch, M.D., president-elect of the American Society of Cosmetic Dermatology and Aesthetic Surgery, says the new regulations "are long overdue and a welcome advisory for consumers."

The proposed changes were announced Aug. 23, with the FDA to accept public comments for 90 days.