A carcinogen was found in 78 batches of sunscreen products tested by online pharmacy Valisure, with some batches containing more than three times the FDA limit, the company said this week.
Valisure, a pharmacy company that tests prescription drugs and drug products before they reach consumers, said May 25 it found high levels of benzene in some of the sunscreen products, which are considered drug products by the FDA. Benzene is an industrial chemical known to cause cancer and other potentially serious health risks.
The pharmacy tested 294 batches of sunscreen from 69 companies and found 78 that contained benzene. Some batches of sunscreen contained up to three times the FDA concentration limit of benzene, which is two parts per million.
Of the 294 batches tested by Valisure, 14 from four different brands contained between 2.78 parts per million to 6.26 parts per million of benzene. Twenty-six batches from eight brands contained between 0.11 parts per million to 1.99 parts per million, and 38 batches from 17 brands contained less than 0.1 parts per million of benzene.
The toxicity of benzene in humans has been well-established for more than 120 years, Valisure said. A 2010 review of benzene research cited by Valisure stated that there is "probably no safe level of exposure" to the chemical.
Benzene is specifically associated with blood cancers such as leukemia, making absorption of the chemical through skin "particularly concerning," Valisure said. There have been multiple FDA studies showing that chemicals in sunscreen products are found in the blood at high levels.
Valisure is asking for a recall of the contaminated sunscreen products and requesting that the FDA better define limits for benzene contamination of drug and cosmetic products.
An FDA spokesperson told Becker's Hospital Review: "The FDA takes seriously any safety concerns raised about products we regulate, including sunscreen. While the agency evaluates the submitted citizen petition, we will continue to monitor the sunscreen marketplace and manufacturing efforts to help ensure the availability of safe sunscreens for U.S. consumers."
The spokesperson added that the FDA "reminds manufacturers, distributors, repackagers and importers they are responsible for the quality of their products and urges manufacturers to test their ingredients to ensure they meet specifications and are free from harmful contamination."
Read the full Valisure report here.