FDA Announces New Rules for Sunscreen Labels

Article date: June 14, 2011

By Stacy Simon

The Food and Drug Administration (FDA) is announcing new rules for labeling sunscreens, to take effect for most manufacturers in one year. The rules are designed to give consumers better information about which sunscreen products offer the most protection from both ultraviolet A (UVA) and ultraviolet B (UVB) exposure, which contribute to sunburn, skin cancer, and premature skin aging.

Under the new rules, sunscreens that pass the FDA’s test for protection against both UVA and UVB rays can be labeled as “broad spectrum.” Sunscreens that are broad spectrum and have a sun protection factor (SPF) of 15 or higher may state that they reduce the risk of skin cancer and early skin aging. Products that don’t meet this standard will require a warning on the label.

In addition, claims about water resistance on the front label must make clear whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating. Sunscreen makers will no longer be able to label products with the terms "waterproof" or "sweatproof," because these claims overstate their effectiveness.

Len Lichtenfeld, M.D., American Cancer Society deputy chief medical officer, says, "To date, there have not been consistent rules governing the testing, labeling and effectiveness of sunscreens in this country. This new FDA rule establishes clear guidelines on how these products are labeled and specifies what tests have to be done to provide consumers some assurance that sunscreen products will perform as intended and as described on the package label.”

More Labeling Changes Possible

The FDA is also proposing some additional changes that could affect sunscreens in the future. One proposal is to limit the maximum SPF on labels to “50+” because there isn’t enough information to prove that sunscreens with SPFs higher than 50 provide any greater protection for users.

The FDA is also requesting information on the spray form of sunscreens. The FDA says spraying sunscreen on the skin rather than rubbing it in may change its effectiveness.

"Being out-of-doors is part of a healthy and enjoyable lifestyle,” says Lichtenfeld. “We need to continue to emphasize—as did the FDA—that sunscreen is but one part of effective sun-safe behavior when you are outside in the sun. Avoiding the sun at peak hours, wearing a broad-brimmed hat, wearing protective clothing and sunglasses that block UV rays—in addition to applying the correct amount of sunscreen—are all important factors in reducing your risk of skin cancer when you are exposed to the sun for any length of time."

To learn more about how to protect your skin from the sun and lower your risk of skin cancer, visit cancer.org/sunsafety.

Reviewed by: Members of the ACS Medical Content Staff

ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases.