Medical research has exposed serious gaps in the regulation of sunscreen and after-sun products. The FDA considers benzene a “Class 1 Solvent” and outlaws its use in most cosmetics and most medical products. However, the agency does little to enforce these regulations or require that manufacturers ensure they are safe.

  • Sunscreen products fall under the FDA’s regulations for over-the-counter drugs. The agency has the power to regulate testing, manufacturing, labeling, advertising, marketing, efficacy, and safety of these products. In practice, the FDA has a limited budget and resources to ensure that manufacturers are producing safe products.
  • After-sun products are considered cosmetics by the FDA, which means these products do not require FDA approval before going on the market. Once on the market, manufacturers are not required to demonstrate that products or ingredients are safe, and they are not required to share safety information with the FDA.
  • Along with its limited regulatory power, resources and funding, the FDA’s independence is subject to political pressure and corporate lobbying.
  • The FDA’s enforcement power is often limited to working with manufacturers on voluntary recalls of defective drugs and products. At this time, there is growing movement for a recall of benzene-contaminated sun-care products.
Relying on industry self-reporting of analytical results is not sufficient protection from potentially dangerous contamination
Valisure report 2021

While FDA oversight may be toothless, companies like Johnson & Johnson, which makes Neutrogena brand products, have a legal responsibility to ensure the safety of their products. These companies can be held responsible in civil courts for injuries caused by dangerous and defective products.

In recent cases, juries have returned verdicts against Johnson & Johnson on behalf of individuals who have developed ovarian cancer after exposure to talcum powder products. J&J has also been held responsible for injuries caused by defective hip implants and other medical devices.

The Beasley Allen Law Firm has extensive experience investigating product defect cases and is actively investigating how companies like Johnson & Johnson allowed sunscreen products to be contaminated with benzene.