Sunscreen Users Could Get Burned, Asserts Critics

WASHINGTON, June 21 -- Most of the sunscreen on the U.S. market either fall short of their claims or contain unsafe ingredients, according to an environmental watchdog group here.

In an analysis of 785 different sunscreen products, the Environmental Working Group found that 84% of those with a sun-protection factor (SPF) of 15 or higher did not give users the protection they boasted.

"Only 16% of the products on the market are both safe and effective, blocking both ultraviolet A and ultraviolet B radiation, remaining stable in sunlight, and containing few if any ingredients with significant known or suspected health hazards," the group wrote in a report.

More than half of the products contained unstable ingredients that can break down under sunlight, leaving the user unwittingly exposed, and many products make unsupported claims about efficacy or stability, the report's authors asserted.

The group posted its findings on a Web site, including products that it found to be acceptable and unacceptable sunscreen.

"EWG has conducted this research because the FDA has failed to do so," said Jane Houlihan, vice-president for research at the Environmental Working Group. "With over one million cases of skin cancer reported each year people should have the most reliable information available about which sunscreens will provide the best protection for themselves and their families."

However, the group offered no assurances that use of the products it found acceptable would reduce the rate of non-melanoma skin cancer or malignant melanoma, compared with products it found unacceptable. The group did no such studies, said a spokesperson.

A cosmetic industry spokesman was critical of the report, pointing out that the group did not actually test any product.

"What they're saying is not backed by any fact or study or anything else that would allow the types of conclusions that they're presenting to actually be reached," said John Bailey, Ph.D., chief scientist for the Cosmetic, Toiletry and Fragrance Association, in an interview.

"You can take virtually every point that they make and point to the efforts that the manufacturers take to make sure that the products are safe and effective, [as well as] FDA's oversight and the state of the science, and counter it with something that's more factual than what they're doing."

Robert S. Stern, M.D., chairman of dermatology at Beth Israel Deaconess Medical Center in Boston, and a supporter of sunscreen in general, questioned whether the group had sufficient data to judge the relative merits and safety of myriad products.

"Whatever their methodology, the amount of data that goes into determining SPF and the degree to which UVA protection is important and how important it is are still things that are not very well known," said Dr. Stern.

The Environmental Working Group is a Washington-based not-for-profit watchdog group that focuses on issues such as food safety, consumer products, and chemicals in the environment. The group is described by Consumers Union as a research and advocacy organization, and is cited in Consumer Reports for its research into organic foods and food safety.

The group is a lightning rod for conservative groups, such as the Capital Research Center, which ranks it as the fifth "worst environmental group," accusing it as a "peddler of fear" and "junk science specialist."

In its study, the group used a proprietary methodology to review nearly 400 documents, including scientific studies, industry models of sunscreen efficacy, and toxicity and regulatory data from government, academic, and industry databases to come up with practical recommendations for consumers.

Their key findings included:

• Many sunscreen ingredients break down under sunlight, allowing exposure of skin to UV radiation.
• Nearly half of all products make claims for their product -- such as "waterproof," "all-day protection," or "blocks all harmful rays" -- that are not backed by evidence
• Several of the top-rated sunscreens contain zinc oxide and/or titanium dioxide in micronized or nano-particle form. Although these ingredients are generally thought to be safe and effective, untested micro-particle formulations of other chemicals are contained in some products and could be harmful if absorbed through the skin.
• Among high SPF sunscreens defined as those with an SPF of at least 30, 13% protect only against the burning rays of UVB, and not against light in the UVA spectrum, which is associated with accelerated skin aging and skin cancer.

David L. Mitchell, Ph.D., a photobiologist in the department of carcinogenesis at the University of Texas M.D. Anderson Cancer Center in Houston, agreed in an interview that there is growing evidence for the need to effectively block UVA as well as UVB.

"UVA may be carcinogenic, and it's becoming more and more evident that the molecular ingredients are there for it to be carcinogenic, and it certainly causes aging of the skin," Dr Mitchell said. "There is some evidence for immunosuppression, and there have been papers published to show that it causes basal-cell carcinomas in humans and squamous-cell carcinomas in mouse models. The real question has been melanoma."

Dr. Mitchell also agreed with environmental group's contention that European research and development of sunscreens is superior to that of the United States, noting that the French cosmetic firm L'Oreal developed a UVA blocking sunscreen called Mexoryl, but "it took the FDA I don't know how many years to approve it in this country, and it's a good UVA block."

Dr. Stern recommended choosing a sunscreen with a sufficiently high SPF (usually 15 or greater) and a vehicle -- cream, lotion, gel, or spray -- with which the patient is most comfortable.

"A sunscreen that stays in the bottle has an SPF of zero," he said.

The Environmental Working Groups rankings of sunscreens are posted on their website, at http://www.ewg.org/sunscreen/.