FDA Releases a Final Sunscreen Rule

Posted: June 16, 2011

After nearly a four-year wait for an action on sunscreens, the US Food and Drug Administration (FDA) has issued a Final Sunscreen Rule, which addresses the testing and labeling of OTC sunscreen products. In addition to the Final Rule, the FDA published a Draft Enforcement Guidance for Industry document, further explaining the Final Rule; a Proposed Rule on sunscreens with SPFs greater than 50+; and an Advance Notice of Proposed Rulemaking (ANPR), recognizing and requesting information about alternative dosage forms of sunscreen products such as sprays, powders, wipes and shampoos.

The Final Rule requires a Broad-spectrum Test, which tests a product's breadth of UVA protection and UVB protection coupled with the SPF value, before a "Broad-spectrum SPF [Value]" claim can be printed on the product's label. This test measures the product's critical wavelength (cw), where sunscreens with a cw of at least 370 are considered broad-spectrum. If sunscreens do not pass this test, manufacturers cannot print a broad-spectrum claim on their label.

In addition, products with a broad-spectrum protection of SPF 15 or higher can claim to reduce the risk of skin cancer or early aging if used as directed. Sunscreens that do not pass the broad-spectrum test (<370 cw) and broad-spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn and must carry a warning on their label that reads "Skin Cancer/Skin Aging Alert."

Manufacturers cannot label sunscreens as "waterproof" or "sweatproof," or identify their products as "sunblocks" because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hr without re-application, or claim to provide immediate sun protection without data supporting these claims and FDA approval. Manufacturers, however, can claim "water-resistant" by labeling the front of the product with a 40 min. or 80 min. protection limit for activities such as swimming or sweating based on standard testing. Sunscreens that are not water-resistant must instruct consumers to use a water-resistant sunscreen if swimming or sweating.

Finally, all sunscreens are required to include standard "Drug Facts" information on the back and/or side of the container.