Benzophenone is a mutagen, carcinogen,
and endocrine disruptor.
Its presence in food products or food packaging is banned in the United
States. Under California Proposition 65, there is no safe harbor for
benzophenone in any personal care products, including sunscreens,
anti-aging creams, and moisturizers. The purpose of this study was
to determine (1) if benzophenone was present in a wide variety of
commercial sun protection factor (SPF)/sunscreen products, (2) whether
benzophenone concentration in the product increased over time, and
(3) if the degradation of octocrylene was the likely source for benzophenone
contamination. Benzophenone concentration was assayed in nine commercial
sunscreen products from the European Union and eight from the United
States (in triplicate), including two single ingredient sources of
octocrylene. These same SPF items were subjected to the United States
Food and Drug Administration (U.S. FDA)-accelerated stability aging
protocol for 6 weeks. Benzophenone was measured in the accelerated-aged
products. Sixteen octocrylene-containing product lines that were recently
purchased had an average concentration of 39 mg/kg benzophenone, ranging
from 6 mg/kg to 186 mg/kg. Benzophenone was not detectable in the
product that did not contain octocrylene. After subjecting the 17
products to the U.S. FDA-accelerated stability method, the 16 octocrylene-containing
products had an average concentration of 75 mg/kg, ranging from 9.8
mg/kg to 435 mg/kg. Benzophenone was not detectable in the product
that did not contain octocrylene. Benzophenone was detected in the
pure octocrylene manufactured ingredient. Octocrylene generates benzophenone
through a retro-aldol condensation. In vivo, up to
70% of the benzophenone in these sunscreen products may be absorbed
through the skin. U.S. FDA has established a zero tolerance for benzophenone
as a food additive. In the United States, there were 2999 SPF products
containing octocrylene in 2019. The safety of octocrylene as a benzophenone
generator in SPF or any consumer products should be expeditiously
reviewed by regulatory agencies.