As early as June 2012, sunscreens that fail “broad spectrum” tests or have an SPF less than 15 must warn that they have not been shown to prevent cancer or early skin aging, according to an FDA final rule.

Conversely, the rule announced June 14 allows products with SPF 15 or higher and that meet new broad spectrum tests, which measure UVA and UVB protection, to claim they decrease the risk of skin cancer or early skin aging caused by the sun.

The testing and labeling requirements established by the rule are part of FDA's ongoing efforts to ensure "manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit," Janet Woodcock, director of the Center for Drug Evaluation and Research, said in a release.

"It wasn't until fairly recently that FDA scientists had sufficient data to establish an accurate and reliable broad spectrum test” for protection against both UVB radiation, which is responsible for sunburns, and UVA, which contributes to sunburn, skin cancer risks and premature skin aging, Woodcock said during a same-day media briefing.

The final rule, which includes several other claim and label changes, codifies "the best way to test for broad spectrum protection and then to label sunscreen products in a scientifically valid manner that users can also easily understand," she added.

The rule will go into effect June 18, 2012, for products with annual sales of more than $25,000, and a year later for other products.

The agency simultaneously released a separate proposed rule to ban sun-protection factor values higher than 50 ( Also see "FDA Considers Capping SPF Values At 50+ Despite Efficacy Data" - Pink Sheet, 20 June, 2011. ).

FDA also released an advanced notice of proposed rulemaking to gather more information about sunscreen dosage forms and a draft enforcement guidance to help industry comply with all three regulatory documents. The final and proposed rules and the ANPR were published in the June 17 Federal Register

The final rule is not the long-awaited OTC sunscreen ingredients final monograph, but addresses some issues raised in the 2007 proposed monograph. FDA notes in the final labeling rule that it is still evaluating other issues raised in comments to the proposed monograph and will address them separately in future (Also see "Sunscreen Proposed Rule May Create UVA Protection Marketing Opportunity" - Pink Sheet, 27 August, 2007.).

When Cancer Warnings And Claims Apply

FDA will consider sunscreen products "broad spectrum" only if they meet specific tests in the rule that show they protect against UVA and UVB rays in proportion and have a critical wavelength equal to or greater than 370 nm, according to the final rule.

In addition, only broad spectrum products with an SPF of 15 or higher can include the consumer-appealing claim "use as directed reduces the risk of early skin aging and skin cancer when used with other sun protection measures."

All other products, including non-broad spectrum sunscreens and sunscreens with SPF 2 to 14, cannot make this cancer protection claim, FDA adds.

The new rule deviates from current practice. Presently, FDA requires only testing and labeling for SPF, but does not clearly define it. As a result, SPF now mostly measures UVB protection, and there are no current labeling standards for UVA protection. Firms use different measures to establish SPF, which makes comparing sunscreens difficult for consumers.

Key Changes In Final Labeling Rule

FDA abandoned its controversial proposal for a UVA "star rating" in favor of a combined "broad spectrum SPF" statement
FDA defines UVA and UVB broad spectrum tests that products must pass to make cancer protection claims
A new "sun alert" warning must be added to non-broad spectrum products with SPF less than 15
"Waterproof," "sweatproof," "sunblock," "all day protection" and "instant protection" claims are prohibitied
Water resistance claims on the front of pages must include the number of minutes a product works while a user sweats or swims
Drug Facts boxes must now appear on sunscreen products

Under the new rule, SPF for broad spectrum products will refer to the overall protection from sunburn-causing UVB rays and cancer-causing UVA rays. SPF for non-broad spectrum products will refer only to UVB or sunburn protection, which creates a need for a warning that the products do not protect against skin cancer and aging.

The warning, which could discourage consumer purchases, will appear as the first bullet in the appropriate section of the drug facts box, which the rule also requires now appear on OTC sunscreens.

As stated in the final rule, the warning must say: "Skin Cancer/Skin Aging Alert [in bold font]: Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown only to help prevent sunburn, not [in bold font] skin cancer or early skin aging."

FDA Bars Or Revamps Some Claims

The final rule also prohibits claims that FDA says overstate sunscreens' efficacy, such as "waterproof," "sweatproof" and "sunblock," and assertions that the product works instantly or for more than two hours without reapplication.

Firms that want to make these claims must submit additional supporting data and obtain FDA approval, or they can make water resistance claims on the front label instead, according to the new rule.

Products that make water resistance claims must indicate how many minutes the sunscreen remains effective while swimming or perspiring based on standard testing, FDA adds.

Finally, under the rule, sunscreens that are not water resistant now must direct users to use a water resistant sunscreen when they swim or perspire.

Estimated Industry Impact

FDA estimates the one-time cost to comply with these label changes is $7,454 to $18,785 per SKU depending on the type of labeling and packaging. This will affect about half of the 3,591 SKUs available, FDA says.

The cost of SPF retesting will vary by test, but could set firms back as much as $4,860 for water resistant products with SPF less than 30, $5,130 for water resistant products with SPF more than 30 and $3,240 for SPF static testing, according to the rule.

About 65% of existing SKUs already meet the criteria for the broad spectrum statement, and those that were tested according to the broad spectrum test do not need to be re-tested, FDA says. Those that were not can expect a cost of $300 to $800 for broad spectrum tests.

Among the brands that already meet FDA's testing requirements for UVA and UVB testing are Energizer Personal Care's Banana Boat and Hawaiian Tropic sunscreens with SPFs of 15 or higher, the Shelton, Conn., firm says in a June 14 statement.

FDA provided this package mock-up for a hypothetical sunscreen product to demonstrate new claims under the final sunscreen labeling rule.

FDA provided this package mock-up for a hypothetical sunscreen product to demonstrate new claims under the final sunscreen labeling rule.

Likewise, "the new rules mainly affect the labeling of sunscreens and will not require a change in Banana Boat and Hawaiian Tropic brand sunscreen formulas," the firm says.

Johnson & Johnson, which markets Aveeno and Neutrogena, also already has adopted many of FDA's recommendations, including its guidance on testing UVA protection as well as UVB, the firm said June 15.

The grace period for compliance, however, might be too short, the Personal Care Products Council says.

The 12 months the rule gives some firms for compliance might not be enough "given the thousands of products on the market, the limited number of testing facilities and the time needed to redesign product labeling," the industry trade group said in a release.

"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 council notes.

Overall, though, the council says the labeling clarity in the final rule will help industry and FDA achieve their "mutual goal of ensuring that consumers are protecting themselves against the sun and are aware of the benefits sunscreen products provide."

FDA provided this sample "Drug Facts" box for a hypothetical sunscreen product to demonstrate new claims and warnings.

FDA Continues To Investigate Ingredients

The council also said it was "pleased FDA reaffirmed that there are no safety issues with any of the sunscreen active ingredients, including nanoscale titanium dioxide and zinc oxide."

Animal testing conducted by FDA on nanoscale sunscreen ingredients found they did not penetrate the skin as some feared, Woodcock said. There results agree with published literature (Also see "Nanotech May Bring "Unpredictable Changes" To Sunscreen - Report" - Pink Sheet, 31 August, 2009.).

"The ingredients in sunscreens that are marketed today have been used for many years and FDA does not currently have reason to warn consumers about their safety," she said.

However, the agency is reviewing the ingredients similarly to how it reviewed the safety and efficacy of acetaminophen, Woodcock added. For this reason, the final rule does not address these issues.

"If we determine that any of the active ingredients, including nano-particles, do not meet the safety standards we have established for drugs in this country, the agency will notify the public and work to remove that ingredient from the market promptly," Woodcock added.

Congress Keeps An Eye On Sunscreens

The testing and labeling final rule follows repeated calls from Congress for completion of the OTC sunscreen ingredient monograph.

The changes in the rule are "a victory for consumers that is long overdue," Sen. Jack Reed says in a release.

FDA has considered revising the sunscreen regulations for nearly 30 years and "these new rules outlined by the FDA … are a positive step in the right direction," said Reed.

The Rhode Island Democrat authored the proposed Sunscreen Labeling Protection Act, which would have required FDA to implement a labeling system in a timely manner (Also see "Hill In Brief" - Pink Sheet, 30 May, 2011., Hill In Brief).

Reed adds he "will continue to monitor this process closely to ensure they are implemented in a timely manner."

By Elizabeth Crawford

FDA Strengthens Sunscreen Testing And Label Requirements

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