The Food and Drug Administration has unveiled new labeling rules that give consumers more information about the scope of protection and efficacy of sunscreen products.

Food and Drug Administration, FDA, sunscreen, labeling, sunscreen labeling, sunscreen products, broad spectrum, UVA, UVB, ultraviolet A, ultraviolet B, sunburn, skin cancer, premature skin aging, UVB radiation, SPF, SPF 15, SPF 50+, Janet Woodcock, Center for Drug Evaluation and Research, CDER, sunscreen labels, early skin aging, SPF value, American Academy of Dermatology Association, Ronald Moy, sunscreen regulations, Personal Care Products Council, Energizer Personal Care, Banana Boat, Hawaiian Tropic, Beth St. Raymond

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New FDA rules aim to simplify sunscreen labeling

June 14th, 2011

SILVER SPRING, Md. – The Food and Drug Administration has unveiled new labeling rules that give consumers more information about the scope of protection and efficacy of sunscreen products.

On Tuesday the FDA said its final regulation allows sunscreen products that pass the the agency'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, with sunburn primarily caused by UVB radiation, according to the FDA.

Under the FDA's new labeling rules, sunscreens labeled as both broad spectrum and SPF 15 or higher will help prevent sunburn, lower the risk of skin cancer and reduce the risk of early skin aging if used regularly and as directed, as well as in combination with other sun protection measures.

"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," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER), said in a statement. "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 with 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, the FDA said. 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 noted. "Not only should consumers regularly apply and reapply sunscreens with broad spectrum and SPF of 15 or higher, they should also limit sun exposure."

Also, the FDA proposed a rule that 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 agency said the proposal creates the opportunity for the submission of data to support including higher SPF values in the final rule.

The FDA, too, released an Advance Notice of Proposed Rulemaking (ANPR) for Dosage Forms that it said will give the public a time period to submit requested data addressing the effectiveness and the safety of sunscreen sprays — as well as other sunscreen dosage forms like wipes, powders and shampoos — 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.

In addition, the agency issued a Draft Enforcement Guidance for Industry document that outlines information to help sunscreen manufacturers understand how to label and test their products in light of the new final rule and other regulatory initiatives.

The FDA added that it's also re-examining the safety information available for active ingredients included in sunscreens now on the market. The agency noted that ingredients in sunscreens marketed today have been used for many years and that it doesn't have any reason to believe those products aren' 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.

The American Academy of Dermatology Association on Tuesday hailed the FDA's new sunscreen regulations, saying that the rules will help Americans reduce their risk for skin cancer by guiding them to the most effective sunscreens and advising them on other sun protection measures.

"For the first time, the FDA has clearly defined the testing required to make a broad spectrum protection claim in a sunscreen and indicate which type of sunscreen can reduce skin cancer risk," commented dermatologist Ronald Moy, president of the academy.

"The FDA's sunscreen regulations will take the guesswork out of choosing an effective sunscreen," Moy noted. "The regulations require more descriptive label information that will help consumers make informed decisions about buying and using sunscreen products, and taking other steps to protect their skin."

On Tuesday, the Personal Care Products Council, a trade association representing the global cosmetic and personal care products industry, expressed support for the new FDA rules but said the time frame for manufacturers to comply may be too short.

"We are evaluating FDA's specified implementation period, but 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," the Personal Care Products Council said in a statement.

"The industry and the FDA share a mutual goal of ensuring that consumers are protecting themselves against the sun and are aware of the benefits sunscreen products provide. The labeling clarity the final rule provides will help achieve this goal," the council added.

The group also pointed out that in the FDA's proposed rule the agency acknowledged that SPFs higher than 50 have been substantiated by independent clinical testing labs. "We look forward to working further with the agency on this issue. Individual companies may also provide their own additional data supporting SPFs higher than 50," the council stated.

"We urge the agency to keep this rulemaking current and evolving to accommodate new scientific research that becomes available and enable companies to continue to innovate by producing products with higher SPFs, new effective ingredients, new dosage forms and even additional public health benefits," the group commented.

Energizer Personal Care, maker of the Banana Boat and Hawaiian Tropic sun care brands, said Tuesday that it has already adopted many of the labeling practices announced by the FDA.

For example, Energizer said the FDA's new rule will require sunscreen makers to include a "Drug Facts box" and to use the term "water-resistant," instead of the improper "waterproof" or "sweatproof." The company noted that it currently uses a Drug Facts box on Banana Boat and Hawaiian Tropic sunscreens and labels its products as "water-resistant."

In addition, Energizer said that all Banana Boat and Hawaiian Tropic sunscreen products with SPFs of 15 and higher meet the FDA's testing requirements to provide broad spectrum UVA and UVB protection. The company added that it will adopt the new broad spectrum labeling format in time to meet the FDA's deadline.

"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," stated Beth St. Raymond, marketing director for Banana Boat and Hawaiian Tropic.

Energizer pointed out that the new rules mainly affect the labeling of sunscreens and won't require a change in its Banana Boat and Hawaiian Tropic sunscreen formulas.

The company, too, gave its take on the FDA's proposal to set an SPF limit of 50+.

"Energizer Personal Care believes that products with SPFs higher than 50+ provide a benefit to those people with a higher sensitivity to sun damage, and also because generally people do not apply the proper amount of sunscreen," the company stated. "The FDA also today requested information about the safety and effectiveness of continuous spray sunscreen products. Energizer Personal Care maintains that continuous spray sunscreens are a safe and effective option for consumers seeking an alternative to lotion sunscreens."