Abstract
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1986 and a previous re-review in 2004, along with updated information regarding product types and concentrations of use. Considering this information, the Panel confirmed that Zinc Phenolsulfonate is safe as a cosmetic ingredient in the present practices of use and concentration as described in this report.
Keywords
The Expert Panel for Cosmetic Ingredient Safety (Panel) first published the Final Report on the Safety of Zinc Phenolsulfonate in 1986. 1 The Panel concluded that Zinc Phenolsulfonate is safe as a cosmetic ingredient in the present practices of use and concentration as described in that safety assessment. Upon re-review in 2004, the Panel reaffirmed the original conclusion, as published in 2006. 2
Frequency (2023/2002) and Concentration (2023/2004) of Use According to Likely Duration and Exposure and by Product Category.
NR – not reported.
*Likely duration and exposure are derived based on product category (see Use Categorization https://www.cir-safety.org/cir-findings).
aIt is possible these products are sprays, but it is not specified whether the reported uses are sprays.
bNot specified whether a spray or a powder, but it is possible the use can be as a spray or a powder; therefore, the information is captured in both categories.
cIt is possible these products are powders, but it is not specified whether the reported uses are powders.
In July 2023, an extensive search of the world’s literature was performed for studies dated 2001 forward, and new data were found.5,6 Zinc Phenolsulfonate is categorized in Annex III of the European Union, that is, the list of substances which cosmetic products must not contain except subject to the restrictions laid down. Zinc Phenolsulfonate is confined to use in deodorants, antiperspirants, and astringent lotions at a maximum concentration of 6% (as % anhydrous substance), and eye contact is to be avoided. 5 Additionally, according to 21CFR 310.545, there are inadequate data to establish general recognition of the safety and effectiveness of Zinc Phenolsulfonate in over-the-counter (OTC) drug products. 6
In summary, the Panel reviewed 2023 frequency and concentration of use data, in addition to new, available, relevant safety data. Considering this information, as well as the information provided in the original safety assessment and the prior re-review document, the Panel reaffirmed the 1986 conclusion. The Panel discussed the possibility for Zinc Phenolsulfonate to be used in cosmetic products which may be incidentally inhaled. A detailed discussion and summary of the Panel’s approach to evaluating incidental inhalation exposures to ingredients in cosmetic products is available at https://www.cir-safety.org/cir-findings.
Footnotes
Author’s Note
Unpublished sources cited in this report are available from the Director, Cosmetic Ingredient Review, 1620 L Street, NW, Suite 1200, Washington, DC 20036, USA.
Author Contributions
The articles in this supplement were sponsored by the Cosmetic Ingredient Review.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review. The Cosmetic Ingredient Review is financially supported by the Personal Care Products Council.