WL-AAJ-Z-W-796

WL-AAJ-Z-W-796- 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-AAJ-Z-W-796
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63931-4414
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	128 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SQUALANE (UNII: GW89575KF9)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYESTER-7 (UNII: 0841698D2F)
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
PHENYLPROPANOL (UNII: 0F897O3O4M)
CARRAGEENAN (UNII: 5C69YCD2YJ)
ISOAMYL LAURATE (UNII: M1SLX00M3M)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63931-4414-1	160000000 mL in 1 DRUM; Type 0: Not a Combination Product	06/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/28/2021

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Cirporation (623502044)