Label: WL-AAN-Z-A-822- zinc oxide stick
- NDC Code(s): 63931-4384-1
- 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 December 22, 2021
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- WL-AAN-Z-A-822
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INGREDIENTS AND APPEARANCE
WL-AAN-Z-A-822
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4384 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 mg in 1 g Inactive Ingredients Ingredient Name Strength PHYSALIS ANGULATA (UNII: W4TKW9D5GG) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB) DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) SQUALANE (UNII: GW89575KF9) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) TRIBEHENIN (UNII: 8OC9U7TQZ0) METHYLPROPANEDIOL (UNII: N8F53B3R4R) NYLON-12 (UNII: 446U8J075B) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) PHENYLPROPANOL (UNII: 0F897O3O4M) TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO) CANDELILLA WAX (UNII: WL0328HX19) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4384-1 160000 g in 1 DRUM; Type 0: Not a Combination Product 02/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2020 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(63931-4384) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(63931-4384) , manufacture(63931-4384) , pack(63931-4384) Establishment Name Address ID/FEI Business Operations Amcol Health & Beauty Solutions 872684803 api manufacture(63931-4384)
