FDA overhauls sunscreen labeling to provide clarity

An example from the FDA of new sunscreen labels

The sun care segment is in the midst of some significant changes as, years after announcing its intent to improve the labeling of sunscreens, the Food and Drug Administration finally has issued new rules for OTC sunscreen products. For consumers, it should mean less confusion when buying products. For manufacturers, it will mean ensuring that they meet the new labeling and testing requirements.

Lydia Velazquez in the FDA’s division of Nonprescription Regulation Development stated that these measures were necessary because “our scientific understanding has grown. We want consumers to understand that not all sunscreens are created equal.”

“This new information will help consumers know which products offer the best protection from the harmful rays of the sun,” Velazquez added. “It is important for consumers to read the entire label, both front and back, in order to choose the appropriate sunscreen for their needs.”

Under the new regulations, all OTC sunscreen products by summer 2012 will be required to meet certain standards. Because the relative economic impact is greater for products with lower sales volume, which disproportionately could affect smaller manufacturers, the FDA has provided a longer implementation period (two years) for products with annual sales of less than $25,000. Among the new regulation’s main points:

Broad Spectrum designation. Sunscreens that pass the FDA’s broad-spectrum test procedure, which measures a product’s UVA protection relative to its UVB protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described below.

Use claims. Only Broad Spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with an SPF values between 2 and 14 can only claim to help prevent sunburn.

“Waterproof, “sweatproof” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness, the FDA stated. Sunscreens also cannot claim to provide sun protection for more than two hours without reapplication or to provide protection immediately after application (e.g., “instant protection”) without submitting data to support these claims and obtaining FDA approval.

Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water-resistant sunscreen if swimming or sweating.

Drug Facts. All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.

Responding to the release of the final regulations, Beth St. Raymond, marketing director for Energizer Personal Care’s Banana Boat and Hawaiian Tropic brands stated, “Both our Banana Boat and Hawaiian Tropic brand sunscreen formulas, with SPFs higher than 15, already meet the newly announced FDA requirements for providing safe and effective UVA and UVB protection, and we will be implementing the new regulations on broad-spectrum labeling in a timely manner.”


The article above is part of the DSN Category Review Series. For the complete Sun Care Buy-In Report, including extensive charts, data and more analysis, click here.

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