Label: WL-AAD-Z-W-2063- zinc oxide lotion
- NDC Code(s): 63931-2063-1
- 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 August 30, 2023
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- WL-AAD-Z-W-2063
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INGREDIENTS AND APPEARANCE
WL-AAD-Z-W-2063
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-2063 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 LIMONENE, (+/-)- (UNII: 9MC3I34447) ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) RUTIN (UNII: 5G06TVY3R7) JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) FERROUS OXIDE (UNII: G7036X8B5H) HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) TOCOPHEROL (UNII: R0ZB2556P8) SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN) LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCO-CAPRYLATE (UNII: 4828G836N6) NYLON-12 (UNII: 446U8J075B) PHENYLPROPANOL (UNII: 0F897O3O4M) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) METHYLPROPANEDIOL (UNII: N8F53B3R4R) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) ALLANTOIN (UNII: 344S277G0Z) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) .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) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) JOJOBA OIL (UNII: 724GKU717M) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-2063-1 150000 mL in 1 DRUM; Type 0: Not a Combination Product 08/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/30/2023 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(63931-2063) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(63931-2063) , manufacture(63931-2063) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 118812921 manufacture(63931-2063) , pack(63931-2063)
