FDA Questions Spray Sunscreen Safety, Efficacy And Monograph Status

FDA could exclude increasingly popular spray sunscreens from the final monograph unless firms submit sufficient safety and efficacy data, according to an advanced notice of proposed rulemaking.

"Considering the greatly increasing number of sunscreen products formulated as sprays, it is critical that the safety and effectiveness of this dosage form be adequately supported," FDA says in the ANPR published June 17.

FDA issued the ANPR along with a final rule on sunscreen labeling, a proposed rule to cap sun protection values and a draft guidance on the new regulations (Also see "FDA Strengthens Sunscreen Testing And Label Requirements" - Pink Sheet, 20 Jun, 2011.).

While the jury is still out on sprays, FDA also uses the ANPR to pursue eliminating several other sunscreen delivery formats from the monograph: sunscreen wipes, towelettes, powders, body washes and shampoos.

Currently, spray dosage products "lack a safety and efficacy record" comparable to other dosage forms that FDA says it likely will include in the final monograph as generally recognized as safe and effective – such as oils, lotions, creams, gels, butters, pastes, ointments and sticks.

"If we do not obtain sufficient data to support monograph conditions for sunscreen products formulated in certain dosage forms, these products may not be included in the future OTC sunscreen monograph," and firms would need an approved new drug application to market them, FDA warns.

Specifically, FDA wants to know if spray sunscreens provide the same level of protection as other dosage forms with the same SPF based on actual consumer use, how well consumers use sprays and the risk of unintentionally inhaling the spray, Janet Woodcock, director of the Center for Drug Evaluation and Research, said during a same-day media call.

Two firms marketing spray sunscreens – Merck Consumer Care with the Coppertone line and Energizer Personal Care with the Banana Boat and Hawaiian Tropic lines – assert that the products are safe and effective and will satisfy monograph testing.

FDA Questions Efficacy Of Sprays

FDA worries that consumers might receive less protection from sprays compared to other dosage forms – even if the same SPF – because sprays are "dispensed in a more diffuse manner … even when applied directly to the body" and it is unclear how much of the spray is transferred to the skin, the ANPR elaborates.

Likewise, "uniform coverage of sprays may also be difficult to assess, because some sprays are applied in a thin, clear layer which is more difficult to visualize than other dosage forms," according to the ANPR.

"We are worried some people may just take a quick, brief spray of themselves and really not be applying the amount of the sunscreen you need to put on and they will feel protected because of the SPF number," Woodcock explained.

The agency also worries consumers do not follow directions to rub in spray sunscreens and, therefore, might not reap the full product benefit.

FDA Questions On Spray Sunscreens

• What amounts of sunscreen spray do consumers typically dispense and what amounts are effectively transferred to the skin?

• How uniform is the sunscreen application across the sun-exposed area of skin?

• How often do consumers reapply the product?

• If a product is labeled with a direction to rub it into the skin, do consumers typically follow this direction?

• How does rubbing the product into the skin change the effectiveness?

• How do the protection levels (SPF values) when typical amounts are applied compare with those under laboratory conditions?

• Should the SPF and broad spectrum tests be modified to address sprays? If so, how?

• What are the risks associated with inhalation of sunscreen active ingredients and propellants?

• What are typical particle size distributions for sunscreen spray products?

• Are animal toxicity studies necessary for determining the potential for toxicity resulting from inhalation?

• Is the labeling discussed in this document adequate to prevent unintentional inhalation? If no, please provide alternative labeling.

To address these concerns, FDA asks firms to submit data on how much spray consumers typically use, how frequently they reapply, whether they follow spray instructions to rub in the sunscreen, whether rubbing in the product makes a difference in efficacy and how consumer use and lab data on protection compare.

Testing Sprays

FDA also might modify SPF tests to address sprays.

In the ANPR, the agency suggests dispensing spray products into a weighing vessel and then applying the appropriate weight of liquid to test SPF and broad spectrum protection. This would make the spray format more comparable to other formats.

However, the agency also wonders if sprays differ enough from other dosage forms that the SPF values on sprays cannot be compared to other forms. FDA says it needs data to validate the modified test method and remains open to any other supported test alternative.

Merck says that in monograph SPF testing and an outdoor use clinical study, Coppertone clear spray sunscreens deliver the same protection as traditional lotions. The firm presented the research at the 2007 annual meeting of the American Academy of Dermatology.

"Coppertone formulations are rigorously evaluated by independent dermatologists and scientists to ensure they are safe and effective for consumers and meet FDA requirements," the firm said.

Like other firms, Merck welcomes FDA's other new sunscreen labeling rules and says, "all Coppertone products with an SPF of 15 or greater in stores today already meet the FDA's newly announced 2012 standard for 'broad spectrum' protection."

FDA also seeks a validated test method to support "no-rub" labeling on spray products.

In addition, FDA proposes directions for sprays to address its application concerns. The modified directions would tell consumers to "spray [select one of the following: 'liberally' or 'generously'] and spread evenly by hand 15 minutes before sun exposure."

Impact Of Inhalation

The agency also worries the consequences of unintentionally inhaling spray sunscreens could outweigh the benefits and seeks data on its safety.

"We would urge consumers with all aerosol products to make sure you don't breathe them in. We are especially worried about children. Because, you know, children are spinning around and you are trying to catch them with the sunscreen," said Woodcock.

"We are asking for more information about inhalation of these [ingredients] and particle size … so we would know, if the spray is breathed in, where it would go," she added.

The Environmental Working Group does not recommend spray or powdered sunscreens due to concerns about inhalation. It is "especially concerned about inhalation of nano- or micro-sized zinc and titanium in powdered sunscreens."

EWG maintains inhalation “is a much more direct route of exposure to these compounds than dermal penetration, which appears to be low in healthy skin."

Woodcock acknowledged FDA does not know if spray sunscreens include nano-sized particles, but this is an area in which it would like information.

FDA also requests firms submit adverse event reports associated with unintentional inhalation of currently marketed sunscreen sprays.

Energizer Personal Care maintains continuous spray sunscreens are safe and effective. Merck says its Coppertone spray products are designed “to help safeguard against potential inhalation concerns based on government and industry guidelines."

Nonetheless, FDA proposes adding a warning to keep the products away from the face to avoid inhaling the spray, along with directions to hold the container 4 to 6 inches from skin to apply, to use in a ventilated area and directions not to spray directly into face or apply in windy conditions, according to the ANPR.

These suggestions are "to further encourage submission of data" to FDA which is due Sept. 15, the agency says.

By Elizabeth Crawford