Benzophenone Accumulates over Time from the Degradation of Octocrylene in Commercial Sunscreen Products

Abstract

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.

Response to the Letter to the Editor by Dr. Christian Surber

“…Whether benzophenone is present or not in the raw ingredient (and it is present in the raw ingredient), benzophenone will continue to be released by octocrylene “in a time- and temperature-dependent manner”. This is the conclusion that our paper (evaluating 16 octocrylene products) and, to a lesser extent, Foubert et al (evaluating 28 octocrylene products) made, that benzophenone is not an impurity of octocrylene manufacturing, but accumulates through the continual release via degradation in products that were purchased directly from stores. , …”

Optimization method for quantification of sunscreen organic ultraviolet filters in coastal sands

“…This was very useful for BM peak integration because BM peak was split without return to baseline between the two maxima (Figure 1). The concentration calculation is detailed in our previous work [31].…”

UV Filters: Challenges and Prospects

“…This compound tends to promptly decompose after irradiation, forming two photoproducts, one as a result of the loss of methyl group from the initial molecule, and the other product with an extra value of atomic number, probably associated with the oxidation of the amine group, directly linked to the aromatic ring ( Table 1 , 2nd entry) [ 30 ]. It is noteworthy to mention that, recently, it was reported the conversion of octocrylene ( 30 ) into a benzophenone derivative through a retro-aldol condensation reaction, which increases the phototoxic potential of this UV filter [ 32 ].…”