Manufacturers can use any of 27 sunscreen chemicals in Europe but only 17 in the United States (Osterwalder 2010). Seven approved compounds that absorb UVA radiation are available in Europe, but only three in the U.S. Among those approved in Europe are three – Tinosorb S, Tinosorb M and Mexoryl SX – that are between 3.8 times and 5.1 times more protective than avobenzone, the most common UVA filter available in the U.S. (see figure).
Seven years ago, companies began to apply for FDA approval to use some of these compounds. They are still waiting.
An EWG analysis of this year’s products found that nearly all will pass the new FDA test for broad spectrum protection but half are too weak for the European market, where manufacturers voluntarily comply with a European Union recommendation that all sunscreens provide meaningful UVA protection in relation to the sunburn protection factor (SPF), a measure of the product’s ability to shield against UVB rays (European Commission 2006,Colipa 2009).).

Source: EWG analysis of UV protection factor using standard industry sunscreen model (BASF 2010), assuming percentage of active ingredient in product equal to maximum allowable amount, or the concentration a company requested that FDA approve for use in sunscreen in the company’s submitted Time and Extent Application.
Since 1972, the FDA has approved only one new sunscreen ingredient, avobenzone.
In April 2005, CIBA Specialty Chemicals Inc. applied for approval of Tinosorb S and Tinosorb M. Sunscreens in Europe have contained these compounds for a decade; FDA has not yet acted.
L’Oréal submitted an application for Mexoryl SX in September 2007. FDA has not approved that compound for general use in sunscreens but did approve it for use in a small number of specific sunscreens sold under L’Oréal’s “LaRoche-Posay” brand. Mexoryl SX has been on the market in Europe since 1991.
The upshot of FDA’s delays is that Americans have fewer choices and notably poorer UVA protection than is available in Europe.
Tinosorb S and Tinosorb M offer stable, broad spectrum protection and appear to be much better UVA blockers than avobenzone. They penetrate the skin in insignificant amounts, pose fewer potential health risks and possess no known hormone-disrupting properties, unlike ingredients in common U.S. sunscreens.
Mexoryl SX offers strong, photostable protection
In Europe, regulations governing UVA protection do not have the force of law. Europe’s proposed standards for UVA protection are far more stringent than those of the FDA. Under them, European sunscreens would provide UVA protection at least one-third as strong as their sunburn protection, as measured by SPF value (European Commission 2006). The effect of this rule would be to limit SPF values and to balance sunburn protection with protection against other sun-related health problems such as free radical damage and skin cancer. Very few sunscreens on the U.S. market would meet the baseline UVA protection standards proposed in Europe (Osterwalder 2009).



