Label: WL-AAD-Z-W-1374 (ALLEYOOP SHADE 3)- zinc oxide lotion
- NDC Code(s): 63931-4523-1
- 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 February 14, 2023
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- WL-AAD-Z-W-1374 (Alleyoop Shade 3)
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INGREDIENTS AND APPEARANCE
WL-AAD-Z-W-1374 (ALLEYOOP SHADE 3)
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4523 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) JOJOBA OIL (UNII: 724GKU717M) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TOCOPHEROL (UNII: R0ZB2556P8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCO-CAPRYLATE (UNII: 4828G836N6) NYLON-12 (UNII: 446U8J075B) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF) ALLANTOIN (UNII: 344S277G0Z) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) NIACINAMIDE (UNII: 25X51I8RD4) PROPANEDIOL (UNII: 5965N8W85T) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) DIMETHICONE (UNII: 92RU3N3Y1O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4523-1 150000 mL in 1 DRUM; Type 0: Not a Combination Product 12/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/05/2022 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(63931-4523) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(63931-4523) , manufacture(63931-4523) , pack(63931-4523)
