FDA mandates new rules for sunscreen labels

June 21, 2011

FDA announced new testing and labeling requirements for OTC sunscreen products that will help manufacturers better indicate those that when used with other sun protection measures reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn, according to a news release issued by the agency.

FDA announced new testing and labeling requirements for OTC sunscreen products that will help manufacturers better indicate those that when used with other sun protection measures reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn, according to a news release issued by the agency.

The new requirements and several proposed changes for future rules are outlined in 4 regulatory documents that include a Final Rule, a Proposed Rule, an Advance Notice of Proposed Rulemaking (ANPR), and a Draft Guidance for Industry.

According to the final rule, sunscreen products that pass FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays may be labeled as “broad spectrum.” Sunscreens labeled broad spectrum and “SPF 15” (or higher) may state on the back of the product that, if used as directed with other sun protection measures, the product can reduce the risk of skin cancer and early skin aging.

Products that have SPF values between 2 and 14 may be labeled broad spectrum if they pass the required test, but may not state that they reduce the risk of skin cancer and early skin aging. These products, along with those that are not labeled broad spectrum, must carry a warning label that reads: “Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.” 

Manufacturers cannot claim that sunscreens are “waterproof,” “sweatproof,” or identify their products as “sunblocks,” but must indicate whether the declared SPF level of protection remains effective for either 40 minutes or 80 minutes while swimming or sweating, based on standard testing. If not water resistant, the sunscreen label must instruct consumers to use a water-resistant sunscreen if swimming or sweating.

Manufacturers may not add claims that a sunscreen provides instant protection or protection for more than 2 hours without reapplication, unless they submit data and get approval from FDA.

In addition to the final regulations, FDA proposes a rule that would limit the maximum SPF value to “SPF 50+” because there is not sufficient data demonstrating that products with SPF values higher than 50 provide greater protection compared with products carrying SPF values of 50. 

An ANPR invites public comment on possible directions for use of and warnings for sunscreen sprays because the available dosage data is not comparable to that for sunscreens in other dosage forms such as oils, creams, and lotions. Electronic comments can be submitted at www.regulations.gov.

The final regulations become effective June 18, 2012 (for products with annual sales less than $25,000 the date is June 17, 2013); however FDA hopes that manufacturers will implement the new rules well before their effective date. The Draft Guidance for Industry provides information to help manufacturers understand how to label and test their products.

“FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families.”