WL-AAJ-Z-W-914

WL-AAJ-Z-W-914- 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-914
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63931-4421
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
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
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)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63931-4421-1	160000000 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/30/2021

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Cirporation (623502044)