WL-AAJ-Z-W-838- 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-838 (Bulk)

WL-AAJ-Z-W-838

GHS Label

WL-AAJ-Z-W-838 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4386
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
COUMARIN (UNII: A4VZ22K1WT)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
SORBIC ACID (UNII: X045WJ989B)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
SODIUM ASCORBATE (UNII: S033EH8359)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
SULFURIC ACID (UNII: O40UQP6WCF)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SQUALANE (UNII: GW89575KF9)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
PROPANEDIOL (UNII: 5965N8W85T)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
WATER (UNII: 059QF0KO0R)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
.ALPHA.-BISABOLOL, (-)-EPI- (UNII: 37VB7WIC8L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYESTER-7 (UNII: 0841698D2F)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4386-1160000000 mL in 1 DRUM; Type 0: Not a Combination Product03/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/25/2020
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Cirporation (623502044)

Revised: 1/2022
Document Id: d5c80f2e-692b-ca2c-e053-2995a90a4de1
Set id: a52332dc-9206-2271-e053-2995a90a9e06
Version: 2
Effective Time: 20220117
 
Nanophase Technologies Corporation