FDA Announces New Sunscreen Labeling and Testing Regulations

The U.S. Food and Drug Administration (FDA) announced that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn.

The final regulation allows sunscreen products that pass the FDA's test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as "Broad Spectrum." Both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging. Sunburn is primarily caused by UVB radiation.

Under the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.

"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, M.D., 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."

Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.

Any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

"Most skin cancers are caused by sun exposure. FDA encourages consumers to protect themselves," Woodcock added. "Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF of 15 or higher, they should also limit sun exposure."

In addition to the final rule for sunscreen labeling, today the FDA released three additional regulatory documents—a Proposed Rule, an Advance Notice of Proposed Rulemaking (ANPR) for Dosage Forms, and a Draft Enforcement Guidance for Industry.

• The proposed rule would limit the maximum SPF value on sunscreen labels to "50 +" because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50. The proposal creates the opportunity for the submission of data to support including higher SPF values in the final rule. FDA looks forward to receiving public comment on this document.
• The ANPR will allow the public a period of time to submit requested data addressing the effectiveness and the safety of sunscreen sprays and to comment on possible directions and warnings for sprays that the FDA may pursue in the future, among other issues regarding dosage forms for sunscreens.
• The Draft Enforcement Guidance for Industry outlines information to help sunscreen product manufacturers understand how to label and test their products in light of the new final rule and other regulatory initiatives.

To ensure that sunscreen products meet modern safety standards, FDA is also currently reexamining the safety information available for active ingredients included in sunscreens marketed today. The ingredients in sunscreens marketed today have been used for many years and FDA does not have any reason to believe these products are not safe for consumer use.

The new regulations will become effective for most manufacturers in one year. Manufacturers with annual sales less than $25,000 have two years to comply.

For more information, go to www.fda.gov/sunscreen.