Label: WL-AAJ-Z-W-1138- zinc oxide lotion
- NDC Code(s): 63931-4470-1
- 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 March 16, 2022
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- WL-AAJ-Z-W-1138
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INGREDIENTS AND APPEARANCE
WL-AAJ-Z-W-1138
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4470 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 POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TOCOPHEROL (UNII: R0ZB2556P8) SQUALANE (UNII: GW89575KF9) PHENYLPROPANOL (UNII: 0F897O3O4M) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) ALLANTOIN (UNII: 344S277G0Z) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYESTER-7 (UNII: 0841698D2F) COCO-CAPRYLATE (UNII: 4828G836N6) GREEN TEA LEAF (UNII: W2ZU1RY8B0) VITIS VINIFERA SEED (UNII: C34U15ICXA) CYCLODEXTRINS (UNII: 7E6SK9QDT8) CHONDRUS CRISPUS (UNII: OQS23HUA1X) SODIUM BENZOATE (UNII: OJ245FE5EU) MALTODEXTRIN (UNII: 7CVR7L4A2D) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) RUTIN (UNII: 5G06TVY3R7) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CITRULLUS LANATUS WHOLE (UNII: 3J5I6254YO) SODIUM LACTATE (UNII: TU7HW0W0QT) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4470-1 160000000 mL in 1 DRUM; Type 0: Not a Combination Product 03/16/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/16/2022 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Cirporation (623502044)