Label: WL-AAJ-Z-W-838- zinc oxide lotion
- NDC Code(s): 63931-4386-1
- 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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- WL-AAJ-Z-W-838
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INGREDIENTS AND APPEARANCE
WL-AAJ-Z-W-838
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4386 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 mg in 1 mL Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENZYL SALICYLATE (UNII: WAO5MNK9TU) COUMARIN (UNII: A4VZ22K1WT) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) SORBIC ACID (UNII: X045WJ989B) ISOAMYL LAURATE (UNII: M1SLX00M3M) SODIUM ASCORBATE (UNII: S033EH8359) ASCORBYL PALMITATE (UNII: QN83US2B0N) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TOCOPHEROL (UNII: R0ZB2556P8) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) SULFURIC ACID (UNII: O40UQP6WCF) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SQUALANE (UNII: GW89575KF9) PHENYLPROPANOL (UNII: 0F897O3O4M) PROPANEDIOL (UNII: 5965N8W85T) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) WATER (UNII: 059QF0KO0R) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) .ALPHA.-BISABOLOL, (-)-EPI- (UNII: 37VB7WIC8L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) ALLANTOIN (UNII: 344S277G0Z) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYESTER-7 (UNII: 0841698D2F) GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR) SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O) VITIS VINIFERA SEED (UNII: C34U15ICXA) PHENOXYETHANOL (UNII: HIE492ZZ3T) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4386-1 160000000 mL in 1 DRUM; Type 0: Not a Combination Product 03/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/25/2020 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Cirporation (623502044)
