Label: WL-AAD-Z-W-758- zinc oxide lotion
- NDC Code(s): 63931-4368-1
- Packager: Nanophase Technologies Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 17, 2022
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INGREDIENTS AND APPEARANCE
WL-AAD-Z-W-758
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4368 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 132 mg in 1 mL Inactive Ingredients Ingredient Name Strength LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALLANTOIN (UNII: 344S277G0Z) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SQUALANE (UNII: GW89575KF9) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) PROPANEDIOL (UNII: 5965N8W85T) SODIUM CHLORIDE (UNII: 451W47IQ8X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) METHYLPROPANEDIOL (UNII: N8F53B3R4R) PHENYLPROPANOL (UNII: 0F897O3O4M) SHEA BUTTER (UNII: K49155WL9Y) ISOAMYL LAURATE (UNII: M1SLX00M3M) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4368-1 150000 mL in 1 DRUM; Type 0: Not a Combination Product 01/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/15/2020 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(63931-4368) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 manufacture(63931-4368) , api manufacture(63931-4368) , pack(63931-4368)
