Label: WL-AAJ-Z-W-818- zinc oxide lotion
- NDC Code(s): 63931-4416-1
- 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 September 17, 2021
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- WL-AAJ-Z-W-818
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INGREDIENTS AND APPEARANCE
WL-AAJ-Z-W-818
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4416 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 FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ASCORBYL PALMITATE (UNII: QN83US2B0N) SQUALANE (UNII: GW89575KF9) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) ALLANTOIN (UNII: 344S277G0Z) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYESTER-7 (UNII: 0841698D2F) GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STANNOUS OXIDE (UNII: JB2MV9I3LS) MICA (UNII: V8A1AW0880) PHENYLPROPANOL (UNII: 0F897O3O4M) SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W) CARRAGEENAN (UNII: 5C69YCD2YJ) ISOAMYL LAURATE (UNII: M1SLX00M3M) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4416-1 160000000 mL in 1 DRUM; Type 0: Not a Combination Product 06/10/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/10/2021 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Cirporation (623502044)
