Label: WL-AAB-Z-W-1003- zinc oxide lotion
- NDC Code(s): 63931-4439-1
- Packager: Nanophase Technologies Corporation
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated September 10, 2021
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INGREDIENTS AND APPEARANCE
WL-AAB-Z-W-1003
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4439 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 135.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MYRISTYL TRISILOXANE (UNII: J7960S4R1T) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F) ALLANTOIN (UNII: 344S277G0Z) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ISODODECANE (UNII: A8289P68Y2) NIACINAMIDE (UNII: 25X51I8RD4) WATER (UNII: 059QF0KO0R) DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) DEHYDROACETIC ACID (UNII: 2KAG279R6R) PROPANEDIOL (UNII: 5965N8W85T) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) MALTODEXTRIN (UNII: 7CVR7L4A2D) DIMETHICONE (UNII: 92RU3N3Y1O) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M) ISOCETETH-10 (UNII: 1K92T9919H) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) MICA (UNII: V8A1AW0880) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) ZEIN (UNII: 80N308T1NN) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4439-1 150000 mL in 1 DRUM; Type 0: Not a Combination Product 05/06/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/06/2021 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(63931-4439) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 manufacture(63931-4439) , pack(63931-4439) , api manufacture(63931-4439) Establishment Name Address ID/FEI Business Operations Amcol Health & Beauty Solutions 872684803 api manufacture(63931-4439)