WL-AAD-Z-W-1189

WL-AAD-Z-W-1189- zinc oxide lotion
Nanophase Technologies Corporation

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.

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WL-AAD-Z-W-1189
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63931-4482
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
TOCOPHEROL (UNII: R0ZB2556P8)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
COCO-CAPRYLATE (UNII: 4828G836N6)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
NIACINAMIDE (UNII: 25X51I8RD4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
NYLON-12 (UNII: 446U8J075B)
PHENYLPROPANOL (UNII: 0F897O3O4M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63931-4482-1	160000000 mL in 1 DRUM; Type 0: Not a Combination Product	10/22/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/22/2021

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Cirporation (623502044)