But these overdue rules still lag behind modern standards of sun protection.
Significant safety gaps include:
Weak UVA protection, misleading “broad spectrum” label: The FDA standard allows sunscreens to use the term “broad spectrum” to denote that they provide protection from skin-damaging UVA rays. This quality is not reflected in SPF values, which describe the product’s effectiveness in shielding the skin from UVB rays that cause sunburn. The FDA allows American sunscreen makers to claim their products are “broad spectrum” even though they offer much poorer UVA protection than sunscreens sold in other countries. Based on the products in our 2012 database, EWG calculates that half of the products that pass muster with the FDA would not be sold in Europe due to their inadequate UVA protection. There, manufacturers voluntarily comply with a European Union recommendation that all sunscreens provide meaningful UVA protection in relation to SPF (European Commission 2006).
The FDA adopted the world’s weakest standard for broad spectrum protection. Its pass/fail test is based on criteria set 18 years ago (Diffey 1994). Today nearly all sunscreens pass that test, reflecting sunscreen makers’ increased use of UVA filters. But despite dramatic changes in the market, FDA adopted the 18 year-old test with no change. The scientist who originally proposed the test – Dr. Brian Diffey, professor emeritus and former head of the Department of Medical Physics at Newcastle University in the United Kingdom – has said that the FDA is “setting the bar too low” in using his now-outdated metric that does not reflect “the performance of modern sunscreens” (Diffey 2012).
The FDA rule governing the use of the term “broad spectrum” is arguably the worst aspect of its sunscreen regulation. EWG estimates that the agency will allow nearly 90 percent of current sunscreens to claim “broad spectrum protection” without any reformulation (EWG 2012). This lax approach will cause three serious problems for consumers eager to find better sunscreens:
- Little motivation for companies to improve their products
- No way for consumers to differentiate among products that claim to protect from UVA rays
- Labels that overstate product effectiveness
Misleadingly high SPF values still legal: The FDA has proposed to cap SPF values at “50+,” but this does not yet have the force of law. Products with SPF values greater than 50 protect against sunburn but leave consumers at risk for UVA-related skin damage and aging.
Risky vitamin A additive still legal: The FDA has yet to make a safety determination for the additive retinyl palmitate, a form of vitamin A used in one-fourth of sunscreens. Laboratory tests have found that this chemical appears to cause skin tumors and lesions in test animals.
No plans to review sunscreen ingredient safety and efficacy: The FDA has no immediate plans to review evidence of ingredient toxicity, sunscreen instability and other serious allegations of inferior production. Many sunscreen ingredients act as hormones in the body and readily penetrate the skin. FDA scientists have not reviewed most of these ingredients for potential adverse effects.
Sprays and powders still legal: The FDA has not issued binding rules to protect consumers against powders and sprays (FDA 2011a). The agency has called for manufacturers of spray sunscreens to submit additional information about the safety and efficacy of their products, including proof that they can be applied evenly to provide sufficient sun protection. The FDA has expressed concern about the potential for inhalation of spray ingredients and has asked manufacturers for test data examining the risks of inhalation, particle sizes and comments on whether new toxicity studies are needed to identify harmful effects of inhalation. In the meantime, spray products must have labels warning users against excessive inhalation. The agency has not reviewed the safety and efficacy of powder sunscreens and has requested additional data. In the meantime, the agency permits these products to remain on the market.
Still no approval of sunscreens widely used in other countries: The FDA has yet to approve new sunscreen ingredients widely used in other countries. In 2005 and 2007, CIBA Specialty Chemicals Inc. and L’Oréal asked the FDA for permission to formulate their products with sunscreen ingredients widely used abroad. These applications are in limbo.
What is broad spectrum protection? Who needs it?
The term broad spectrum has been plastered on sunscreen labels for at least a decade, but many consumers know little about why broad spectrum protection is essential. The better-known term SPF or sunburn protection factor refers primarily to UVB rays, which burn the skin. SPF ratings have little to do with the sun’s UVA rays, which penetrate deeper into the skin and inflict other types of damage. UVA radiation suppresses the immune system, ages skin, harms connective tissue and elevates the risk of the deadly skin cancer melanoma (IARC 2009, FDA 2007, Godar 2009).
While SPF values are standardized with lab tests, the amount of UVA protection in products is variable and is not linked to the SPF value. The FDA’s rules are the U.S. government’s first legally binding attempt to restrict the use of the term “broad spectrum” to sunscreens that actually offer protection from UVA rays.
Sunscreens were designed in the 1970’s and 80’s to prevent sunburn. But as scientists have learned more about the serious damage caused by more numerous UVA rays, sunscreen experts have designed sunscreens aimed at protecting the skin across the UV spectrum (Osterwalder 2010, Diffey 2009b). Companies following modern sunscreen rules, such as the voluntary standards set by the European Union, balance UVA and UVB protection (Osterwalder 2009). A higher-SPF sunscreen should provide a higher degree of UVA filtering to ensure that people who are protected from sunburn are also protected from skin damage caused by UVA rays. This standardization is needed because the user cannot tell whether a product is working against UVA rays, which don’t cause burning and pain. While many products advertise UVA protection, a large number fall short.
Other shortcomings in sunscreen protections
The FDA has not announced plans to investigate other safety concerns about sunscreens. Laboratory studies indicate that some active ingredients can be toxic in some situations. Some can cause pre-cancerous cell damage, hormone disruption and possibly reduced birth weight and endometriosis (Gulson 1999, Schlumpf 2001, Wolff 2009, Kunisue 2012). Several estrogenic ingredients (octylmethoxycinnamate, octrocrylene, oxybenzone) have been detected in women’s breast milk, raising concerns about toxicity to the gestating fetus and newborns (Schlumpf 2008). Nanoparticles appear to be stable and non-penetrating, but certain forms cause harmful free radicals. Standardization is needed to ensure that nanoscale zinc oxide and titanium dioxide in sunscreens ensure the highest degree of skin protection.
Inactive ingredients may constitute more than 75 percent of a product and undermine skin protection. Inactive ingredients may enable certain chemicals to penetrate the skin more easily, cause cell damage or undermine the stability of UV filters. Retinyl palmitate, a form of vitamin A that is widely used in sunscreens, has been shown to increase skin tumor and lesion formation in laboratory animals (NTP 2011). The FDA should assure the safety and stability of other antioxidants and vitamins in sunscreen.
Strong standards are needed to ensure that sunscreens hold up well on the skin and decrease free radical damage. In developing such standards, the FDA must modernize its assessment of sunscreen ingredients and product efficacy. Stable, non-penetrating UV filters with fewer toxicity concerns, such as Tinosorb and Mexoryl, should be considered for the U.S. market.