WL-AAJ-Z-W-818 by Nanophase Technologies Corporation / Nanophase Technologies Cirporation WL-AAJ-Z-W-818

WL-AAJ-Z-W-818 by

Drug Labeling and Warnings

WL-AAJ-Z-W-818 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation, Nanophase Technologies Cirporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAJ-Z-W-818- 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-818

WL-AAJ-Z-W-818

WL-AAJ-Z-W-818 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4416
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STANNOUS OXIDE (UNII: JB2MV9I3LS)
MICA (UNII: V8A1AW0880)
PHENYLPROPANOL (UNII: 0F897O3O4M)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
CARRAGEENAN (UNII: 5C69YCD2YJ)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4416-1	160000000 mL in 1 DRUM; Type 0: Not a Combination Product	06/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/10/2021

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Cirporation (623502044)

Revised: 9/2021

Document Id: cc31bea3-76ce-00e4-e053-2995a90ad4e4

34390-5

Set id: cc31a001-4fad-223f-e053-2995a90a2c77

Version: 1

Effective Time: 20210917