FDA: New Rules for Sunscreen

June 21, 2011

Notably, the rules include guidance on ultraviolet A (UVA) rays, the type of ray linked to skin cancer and early skin aging.

FDA last week released new rules for oil, cream, and lotion sunscreen products. Notably, the rules include guidance on ultraviolet A (UVA) rays, the type of ray linked to skin cancer and early skin aging. Prior sunscreen rules only addressed ultraviolet B (UVB) rays and their sunburn effects.

In order to better inform consumers about which sunscreens offer greatest protection from both UVA and UVB rays, the rule states:

  • Sunscreens that pass FDA-established tests for protecting against both UVA and UVB rays may be labeled as “broad spectrum,” with the SPF number indicating how much overall protection is provided. Only broad-spectrum sunscreens with SPF values of 15 or higher may tout protection against not only sunburn but also skin cancer and early skin aging when used as directed. (For sunscreens not labeled as “broad spectrum” but that have an SPF number, the SPF number only indicates protection against sunburn.)

  • All sunscreens must be labeled with a Drug Facts panel.

  • Sunscreens cannot be labeled as “waterproof,” “sweatproof,” or as “sunblocks,” as FDA says these are “overstatements.”

  • Sunscreens can only be labeled as “water-resistant” if they pass tests indicated that they remain effective for 40 minutes or 80 minutes while swimming or sweating.

  • Sunscreens cannot carry an SPF higher than 50 because FDA says there is no evidence to show that an SPF higher than 50 provides more protection than products with an SPF of 50.

The rules take effect by next summer, but the agency notes that sunscreen companies may begin making labeling changes before then.

In addition, FDA is seeking public feedback, in the form of Advance Notice of Proposed Rulemaking, for other forms of sunscreen-containing products, including sunscreen sprays, powders, towelettes, body washes, and shampoos.

In response to the news, the Personal Care Products Council noted: “We are also pleased that FDA reaffirmed there are no safety issues with any of the sunscreen active ingredients, including nanoscale titanium dioxide and zinc oxide.”

However, it also noted “…we are concerned about manufacturers’ ability to make the required testing and labeling changes in only 12 months given the thousands of products on the market, the limited number of testing facilities, and the time needed to redesign product labeling. It is unusual for FDA to require such a short implementation period for a rulemaking of this scope. Manufacturers typically require at least two years to design and implement broad-scale, product-wide labeling changes.”