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Zinc Oxide

The color additive zinc oxide is a white or yellow-white amorphous powder manufactured by the French process (described as the indirect process whereby zinc metal isolated from the zinc containing ore is vaporized and then oxidized). According to the FDA, zinc oxide shall be free of impurities other than those named below to the extent that such impurities may be avoided by good manufacturing practice:

Zinc oxide - not less than 99 percent

Cadmium - not more than 15 parts per million

Mercury - not more than 1 part per million

Arsenic - not more than 3 parts per million

Lead - not more than 20 parts per million

SOURCES:

Food and Drug Administration. (2011, April). Subpart B- Drugs, Sec. 73.1991 Zinc oxide. Code of Federal Regulations, 21 (1). Abstract retrieved from Food and Drug Administration Department of Health and Human Services database. (Cite No: 21CFR73.1991).

Frenet, M., Vincent, F., & Boiteau, H. (1983). In vitro dissolution of metallic oxides in human plasma and binding of metals to plasma proteins--effect of chelators (Abstract). Toxicol Eur Res, 5, 131-139.

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