Benzophenone Reported without Proper Warning Statements in Sunscreen Products

In a recent California court case, benzophenone has been reported to be present in sunscreen products sold in US California State without the proper warning statements.

Regulation of Benzophenone under California Prop 65

Pursuant to Proposition 65 on June 22, 2012, California identified and listed benzophenone as a chemical known to be carcinogenic. In a recent California court case (Case No. 100959) and some recently filed 60-Day Notice of Violation documents, benzophenone (CAS RN 119-61-9) has been reported to be present in sunscreen products sold in US California State without the proper warning statements.

Compliance Standard for Sunscreen Products

In one Settlement Agreement, a ‘Compliant Product’ was defined as those products containing benzophenone in concentrations less than or equal to 12.5 parts per million (ppm) when analyzed pursuant to a scientifically reliable application of U.S. Environmental Protection Agency testing methodologies 3580A and 8270C or any other scientifically reliable methodology to determine level of benzophenone. The effective date of this settlement agreement was January 1, 2015.

The settlement also stated that the party shall not manufacture, or cause to be manufactured, or order for distribution or sale in California unless the products are Compliant Products or carry the Proposition warnings specified below.

Product Warnings on Sunscreen Products

The product shall bear clear and reasonable warnings for all products that do not qualify as Compliant Products, in a conspicuous, prominent, easily read and understood way. A warning such as, WARNING: This product contains benzophenone, a chemical known to the State of California to cause cancer, shall be affixed to the packaging, labeling or directly on each product provided for sale in the California State. This warning is for products with only one cancer-causing chemical, benzophenone. A similar approach is necessary if the products are sold via mail order catalog or internet to customers located in California.

US FDA Final Rule on Sunscreen Products

Unlike European countries, sunscreen product falls into the category of Over-The-Counter (OTC) products under US FDA. Only active ingredients listed under 21 CFR Part 352 are permitted for use in sunscreen products and all products shall follow the FDA’s Final Rule on sunscreen Drug Facts labeling. Functional claims on SPF value and broad spectrum, which address the protection against ultraviolet B (UVB) and ultraviolet A (UVA) radiation respectively, as well as water resistance claims, have to be verified using an international method (e.g. FDA) and to ensure the effectiveness of sunscreen products.

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Contact details:

SGS Consumer Testing Services
Queenie Tse
Cosmetics, Personal Care and Household (CPCH)
SGS Hong Kong Limited
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