Sunscreens containing an SPF over 30 will be required to use one collective term, "SPF 30 plus" or "SPF 30+" on labeling under FDA's final sunscreen monograph published in the Federal Register May 21. Due to the projected considerable economic burden on sunscreen manufacturers to comply with the regulation, FDA is extending the proposed 12-month compliance deadline to 24 months (for other provisions of the reg, see chart, p. 6).

The agency received "numerous" comments on the high-SPF issue after proposing an SPF 30 cap on sunscreens in the tentative final monograph. Many comments requested either no limit or a cap of SPF 50, citing, among other points, escalating skin cancer rates, the need for high SPFs in sun-sensitive people and decreased UV ray penetration with high SPF products.

In contrast, other comments supported the limit in an effort to stop the "bidding war" or "horsepower race" between manufacturers. Some comments maintained SPF values over 30 provide only "incremental value" in blocking UV rays and would be an "unnecessary increase in drug exposure."

FDA acknowledges skin cancer statistics are on the rise, and although some consumers still experience sunburn after using SPF 30, use of such products is increasingly popular. In addition, the agency has received no data questioning the safety of high SPF products, and more advanced formulation techniques have allowed the use of lower concentrations of active ingredients.

Upon weighing these issues, the agency concludes, "OTC sunscreen drug products with SPF values over 30 should be available for those sun-sensitive consumers who require such products based upon personal knowledge of their skin's susceptibility to sunburn, experience with specific products, planned sun exposure or the recommendation of a health professional," the notice states.

While FDA agrees "higher SPF values can provide greater relative exposure times and decreased UV radiation transmission," the agency continues to believe the additional protection provided by high SPF products "is extremely small for most people." The agency invites any new test methods for high SPF products for submission for future consideration.

The decision to require SPF 30+ could be considered somewhat of a compromise between consumer groups concerned about consumer confusion and sunscreen manufacturers looking to capitalize on the increased awareness of UV damage.

Industry has been particularly vocal on the subject of SPF caps; most recently, the Cosmetic, Toiletry and Fragrance Association reiterated its 1994 comments in opposition to such a move, stating that limits must be abolished in light of scientific advances ("The Tan Sheet" May 4, 1998, p. 17).

In all, the final monograph allows the use of 16 active sunscreen ingredients, including avobenzone and zinc, which were added to the tentative final reg in 1996 and 1998, respectively. The agency received 433 comments in response to the TFM, including four foreign data petitions.

FDA has taken nearly 21 years to put at least part of the sunscreen reg to rest; the agency issued the advanced notice of public rulemaking Aug. 25, 1978, and the TFM was published May 12, 1993.

Citing concerns that minimum concentration requirements for sunscreen active ingredients could expose consumers to "unnecessary levels of actives," FDA is only requiring maximum levels when used in combination, and is removing the minimum requirement from the final monograph.

However, the concentration of each active used in a combo product must contribute at least an SPF 2 to the finished product. The final sunscreen formulation must have an SPF not less than the number of actives used in combination, multiplied by two, the notice states.

In response to a request that the agency allow different labeling standards for "secondary" sunscreen products, such as moisturizers or lip balms with sunscreen active ingredients, FDA concludes all sunscreen products - whether drug or cosmetic-drug - should be held to identical standards.

The agency also is requiring hair and nail products with sunscreen active ingredients to include a labeling statement informing consumers that the ingredients protect only the intended area of use. For example, a statement could read: "Contains a sunscreen - to protect product color," FDA suggests.

Lip care products, however, will be exempt from certain label warnings. Due to their method of application, lip product packaging is not required to include the "For external use only" warning or cautionary statements regarding use of the product around the eye area.

FDA received other comments requesting exemptions for certain sunscreens, including products that promise an "even tan" and self-tanners with active ingredients added for extra protection.

The comments argued a sunscreen should be considered a drug only if it claims to prevent or treat sunburn. Self tanners with actives, it was argued, would be offering sunburn protection only as a "secondary" indication. The agency disagreed with both comments, saying the presence of a sunscreen active categorizes a product as a drug, regardless of the primary intent of the product.

Self tanners without sunscreens will require labels stating "Warning - This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer and other harmful effects to the skin even if you do not burn."

Because of the potentially serious health effects related to this particular issue, FDA is requiring industry to comply with the warning label requirement for self tanners within 12 months.

FDA addressed a number of other issues regarding sunscreen labeling claims, including its decision to prohibit use of the term "sunblock" on sunscreen product packaging. Several commenters argued the term is unclear and may mislead consumers to think that products carrying the claim completely block UV rays.

The agency agreed with the comments, saying it "is concerned that the term 'sunblock' on the label of sunscreen drug products will be viewed as an absolute term which may mislead or confuse consumers into thinking that the product blocks all light from the sun," the notice states. Thus, the term is now considered nonmonograph.

Use of terms such as "shields from," "protects from," "filters" or "screens out," also are considered nonmonograph. Since sunscreen use alone will not prevent all the potential harmful effects from UV rays, FDA maintains the "statements could provide the wrong message and a false sense of security to some consumers." In addition, claims such as "all-day protection" or those citing a specific number of hours of protection are prohibited.

In general, labeling should concentrate on the sunscreen products use in preventing sunburn, FDA says. Therefore, claims that sunscreens offering protection against "skin aging," "wrinkling," "premature aging" or any other "expansive set of indications is currently unsupported."

However, the voluntary "sun alert" labeling or promotional statements provide information on the role sunscreens play in prevent skin aging "in a context that ensures that the information will not be misleading," FDA points out. In the TFM, the agency had proposed making the "sun alert" educational statements mandatory.

Use of the term "PABA" will need to be accompanied by the full chemical name of the ingredient, aminobenzoic acid. Thus, in place of the PABA-free claims found on many sunscreens, manufacturers must use "aminobenzoic acid (PABA)-free." After a period of time, FDA said it will revisit the topic to determine if the "PABA" reference could be removed altogether.

As expected, the final monograph does not address UVA testing methodologies, which will be discussed in future issues of the Federal Register. Use of the claim that sunscreens prevent against "photoaging" also will be discussed in the future.

Other outstanding topics include the "material time/material extent" issue, which involves agency consideration of foreign marketing data in determining whether ingredients could be included in any OTC final monograph. BASF, Merck, Haarman & Reimer and L'Oreal have been proponents of foreign data consideration.

The use of foreign data also has been a hot topic among U.S. lobbyists, and in turn has been the focus of much correspondence to FDA. The Consumer Healthcare Products Association most recently commented on the matter in December 1996 ("The Tan Sheet" Jan,. 6, 1997, p. 15).

"SPF 30 Plus" Term Required For High-Protection Sunscreens - FDA Final Reg

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