U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) permits zinc sulfate to be used as an ophthalmic astringent in in over-the-counter (OTC) ophthalmic drug products at concentrations of 0.25%. The FDA also considered zinc sulfate to be Generally Recognized As Safe (GRAS) for use as a nutrient, and as an indirect food additive for use in paper and paperboard used for food packaging.

Expert Panel for Cosmetic Ingredient Panel

The Expert Panel for Cosmetic Ingredient Panel has deferred evaluation of this ingredient because the safety has been assessed by the FDA. This deferral of review is according to the provisions of the Expert Panel procedures.

The FDA’s Select Committee on GRAS Substances (SCOGS) concluded that there was no evidence in the available information on zinc sulfate that demonstrates a hazard to the public when it is used at levels that are now current and in the manner now practiced.

http://www.cfsan.fda.gov/~dms/opascogc.html

Link to FDA Code of Federal Regulations for zinc sulfate:

• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Water-soluble zinc salts, including zinc sulfate, are listed in the Cosmetics Directive of the European Union and may be used at a maximum concentration of 1% (calculated as zinc) (see Annex III).

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…