Findings Dispute Sunscreen Effectiveness And Safety   

More Americans than ever are using sunscreen to protect from sunburn and guard against skin cancer. Top choices include products with high SPF ratings, and that are waterproof or that advertise "broad spectrum" protection. Most people trust that the claims on the bottle will ensure that the product truly protects their health and their families'. Nothing could be less certain.

In a new investigation of 952 name-brand sunscreens, the Environmental Working Group (EWG) found that 4 out of 5 sunscreen products offer inadequate protection from the sun, or contain ingredients with significant safety concerns. Leading brands were the worst offenders: None of market leader Coppertone's 41 sunscreen products met EWG's criteria for safety and effectiveness, and only 1 of 103 products from Banana Boat and Neutrogena, the second- and third-largest manufacturers, are recommended by EWG.

Many products on the market present obvious safety and effectiveness concerns, including one of every seven that does not protect from UVA radiation This problem is aggravated by the fact that FDA has not finalized comprehensive sunscreen safety standards they began drafting 30 years ago. Overall we identified 143 products that offer very good sun protection with ingredients that present minimal health risks to users.

More Americans than ever are using sunscreen to protect from sunburn and guard against skin cancer. Top choices include products with high SPF ratings, and that are waterproof or that advertise "broad spectrum" protection. Most people trust that the claims on the bottle will ensure that the product truly protects their health and their families'. Nothing could be less certain.

• Only 15% of 952 products analyzed met EWG's criteria for safety and effectiveness, blocking both UVA and UVB radiation, remaining stable in sunlight, and containing few if any ingredients with significant known or suspected health hazards. Our assessment is based on a detailed review of hundreds of scientific studies, industry models of sunscreen efficacy, and toxicity and regulatory information housed in nearly 60 government, academic, and industry databases.

With no mandatory, comprehensive sunscreen standards in place, products vary widely in safety and effectiveness. FDA has spent the past 30 years drafting sunscreen standards (FDA 2007a), which it urges manufacturers to follow voluntarily. FDA issued its latest draft standards in August 2007, which include a proposal for first-ever UVA standards, but still has failed to finalize the standards to make them mandatory. In lieu of enforceable standards, each sunscreen manufacturer decides on test methods, marketing claims, and the level of protection they are willing and able to provide consumers. Health authorities recommend sunscreen, but people are left wondering which of the hundreds of sunscreens on store shelves will best protect their and their families' skin from the sun.

• Many products lack UVA protection. Our analysis found that 7 percent of high SPF sunscreens (SPF of at least 30) protect only from sunburn (UVB radiation), and do not contain ingredient combinations known to protect from UVA, the sun rays linked to skin damage and aging, immune system problems, and potentially skin cancer. FDA does not require that sunscreens guard against UVA radiation.

Because FDA has failed to set UVA standards, many high SPF sunscreens provide only half the protection you need. People buy high-SPF sunscreens in advance of beach vacations or long days at the pool, assuming they've purchased products that maximize sun protection. High SPF ("Sun Protection Factor") products do protect you from sunburn, the well-known skin cancer precursor caused by the sun's UVB rays. But these products don't necessarily block UVA rays, the more deeply penetrating radiation linked to skin aging and wrinkling, immune system suppression, and possibly skin cancer.

FDA does not require companies to provide UVA protection in sunscreen, and our analyses show that despite high SPF ratings and "broad spectrum" marketing claims, only a fraction of products provide strong UVA protection. We found poor UVA protection in 7% of high SPF products (30 and higher); in 11% of the 507 products marketed as having "broad spectrum" protection; and in 14% of sunscreens overall.

• Sunscreens break down in the sun. Paradoxically, many sunscreen ingredients break down in the sun, in a matter of minutes or hours, and then let UV radiation through to the skin. Our analyses show that 48% of products on the market contain ingredients that may be unstable alone or in combination, raising questions about whether these products last as long as the label says. FDA has not proposed requirements for sunscreen stability.

The study found 459 products contain sunscreens that break down in the sun, with insufficient stabilizing chemicals. It may seem counterintuitive, but of the 17 "active ingredients" that FDA has approved for use as sunscreens in the U.S., at least 4 of them break down significantly when they are exposed to sunlight. They lose their ability to absorb the sun's harmful rays, and stop working effectively in as little as 30 minutes, ranging up to several hours. They require stabilizing chemicals to remain effective.

An ideal sunscreen would be stable in the sun. Instead, nearly every active ingredient (all but zinc oxide and titanium dioxide) works by first absorbing the sun's energy so it doesn't penetrate our skin, and then releasing that captured energy by breaking apart, reacting with other chemicals in the sunscreen, or even kicking off free radicals. Some active ingredients are more stable than others, but nearly all break down to some extent in the sun.

• Questionable product claims are widespread. Many products on the market bear claims that are considered "unacceptable" or misleading under FDA's draft sunscreen safety standards. Claims like "all day protection," "mild as water," and "blocks all harmful rays" are not true, yet are found on bottles. Until FDA sets an effective date for these standards, industry is free to use hyped claims. Companies' decisions to inflate claims has spurred class action lawsuits in California.

Many products would be misbranded if FDA finalized sunscreen standards. With unenforceable draft guidelines in place of mandatory sunscreen standards, companies are free to use marketing terms that FDA has said are confusing, and they are free to sell products that would be considered misbranded if the Agency finalized its guidance (FDA 2007, FDA 1999). Our analysis of products showed that fully 53% of sunscreens were labeled with one or more terms that FDA has said are indicative of a misbranded product, terms that are "unacceptable," or terms that could "mislead consumers by inducing a false sense of security".

These include "chemical-free," "non-chemical," "help prevent skin damage," as well as terms like "sunblock," "reflects," "shields," "protects," "filters," "screens," "sun's rays," "sun's harmful rays," and all SPF designations greater than 50.

In addition to claims specifically targeted by FDA, we found many more that would also mislead consumers, including claims of "sand-proof," "all day" protection, "instant protection" or "as mild as water," none of which is possibly true. Without labeling restrictions, consumers are left wondering what is true. Consumers can be fooled into buying products that don't deliver what they sell. 53% of sunscreens bear claims that the FDA considers unacceptable or indicative of a misbranded product.

• Many sunscreens contain nano-scale ingredients that raise potential concerns. Micronized and nano-scale zinc oxide and titanium dioxide in sunscreen provide strong UVA protection, and are contained in many of our top-rated products. Repeated studies have found that these ingredients do not penetrate healthy skin, indicating that consumers' exposures would be minimal. Powder and spray sunscreens with nano-scale ingredients raise greater concerns, since particles might absorb more easily through the lungs than the skin. Studies of other nano-scale materials have raised concerns about their unique, toxic properties. FDA has failed to approve effective UVA filters available in Europe that, if approved here, could replace nano-scale ingredients.

• Some sunscreens absorb into the blood and raise safety concerns. Our review of the technical literature shows that some sunscreen ingredients absorb into the blood, and some are linked to toxic effects. Some release skin-damaging free radicals in sunlight, some could disrupt hormone systems, several are strongly linked to allergic reactions, and others may build up in the body or the environment. FDA has not established rigorous safety standards for sunscreen ingredients that fully examines these effects. Most sunscreen chemicals are far from innocuous. In sunlight some release free radicals that can damage DNA and cells, promote skin aging, and possibly raise risks for skin cancer. Some act like estrogen and may disrupt normal hormone signaling in the body. Others some may build up in the body and the environment.

The U.S. lags behind other countries when it comes to products that work and are safe. FDA has approved just 17 sunscreen chemicals for use in the U.S. At least 29 are approved for use in the E.U. FDA has approved only 4 chemicals effective in the UVA range for use in the U.S., and has failed to approve new, more effective UVA filters available in the E.U. and Asia.

from Sunscreen Summary - What Works and What's Safe: Authors: Sean Gray, Senior Analyst; Sonya Lunder, MPH, Senior Analyst; Kristan Markey, Analyst (former); Rebecca Sutton, Ph.D., Staff Scientist; Nneka Leiba, MPH, Researcher; Jane Houlihan, Vice President for Research.
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