FDA might cap sun-protection factors at 50 or 50+ so as not to mislead consumers about the clinical benefit of sunscreens with higher SPF values, according to a proposed rule.

"Consumers would likely assume that a product with an SPF value higher than 50 provides greater protection than a product with an SPF value of 50,” FDA says.

However, the agency adds, “we lack evidence that a product with an SPF value higher than 50 provides additional clinical benefit" in actual use than a product with an SPF of 50.

The proposed rule in the June 17 Federal Register accompanied a final rule dictating labeling and testing requirements for monograph sunscreen products ( Also see "FDA Strengthens Sunscreen Testing And Label Requirements" - HBW Insight, 20 June, 2011. ).

FDA Requests Clinical Benefit Data

FDA’s Center for Drug Evaluation and Research acknowledges in the proposed rule that data show SPF values as high as 80 accurately and reliably provide more protection than lower SPF values in lab settings, but it questions whether consumers would be exposed in real-world situations to such intense levels of UV radiation that the extra protection would be needed.

"The theoretical increase in protection implied by higher SPF values generated in the lab does not necessarily correspond to meaningful additional sunburn protection for consumers in actual use conditions where a consumer may be receiving effectively maximal protection against their actual UV exposure with a lower SPF product," the agency says.

Energizer Personal Care, the maker of Banana Boat and Hawaiian Tropic sunscreens, disagrees. It maintains in a June 14 release that "products with SPFs higher than 50+ provide a benefit to those people with higher sensitivity to sun damage and also because generally people do not apply the proper amount of sunscreen."

Johnson & Johnson, which markets Aveeno and Neutrogena sunscreen products, also believes SPF values greater than 50 provide an added benefit and noted June 15 in a statement that it has submitted data to support this position (Also see "J&J Contests FDA-Proposed Cap With Study Championing High SPF Sunscreens" - HBW Insight, 14 February, 2011.).

FDA recognizes that higher SPFs could be of value to some populations and in some circumstances. People predisposed to skin cancers or who ski in high altitudes, for example, could benefit. Different labeling may be necessary for these unique situations,” the agency suggests.

It requests additional data to identify appropriate target populations, but notes firms should discuss potential studies with the agency to ensure they are appropriate.

Higher SPF May Carry Higher Risk?

FDA also shares Energizer's concern that consumers do not use enough sunscreen or use it appropriately.

But the agency argues that higher SPF values could actually exacerbate the problem of UV overexposure because consumers may not reapply sunscreen with a higher SPF as frequently as one with a lower SPF.

"The theoretical increase in protection implied by higher SPF values generated in the lab does not necessarily correspond to meaningful additional sunburn protection for consumers in actual use conditions." – FDA

On its website, the American Academy of Dermatology notes that “UVB protection does not increase proportionately with a designated SPF number.” While a consumer may assume that sunscreen with an SPF of 30 offers twice the protection of SPF 15, in reality the former screens 97% of UVB rays and the latter screens 93%, the organization says.

“Wearing sunscreen should not provide a false sense of security about protection from UVB exposure,” AAD emphasizes. “Using a higher SPF provides greater UVB protection than a lower SPF, but it does not mean that you should stay out in the sun longer.”

FDA is similarly concerned about the false sense of security a high SPF value may instill in consumers, particularly considering the increased risk of skin sensitivity and reaction that comes with higher SPF formulas, which contain significantly higher active ingredient concentrations.

SPF 50 Cap Could Necessitate Reformulating

If FDA opts for an SPF cap of 50 instead of 50+, firms with high-SPF sunscreen products may need to do more than merely relabel.

Capping SPF at 50 would draw a hard line, rendering products with SPFs higher than 50 outright unlawful. Simply labeling such products as “SPF 50” would not pass muster under the monograph, FDA indicates.

If FDA opts for 50+, relabeling would likely suffice for products in the higher SPF range.

Either way, about 2% of current SKUs, or a total of 72 sunscreen products, would need new packaging or to be reformulated if FDA implements the cap. The agency estimates that one-time costs for re-labeling would be between $200,000 and $650,000.

By Elizabeth Crawford

FDA Considers Capping SPF Values At 50+ Despite Efficacy Data

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