WL-AAB-Z-W-1190- 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-AAB-Z-W-1190

WL-AAB-Z-W-1190

GHS label (Bulk)

WL-AAB-Z-W-1190 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4479
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE132 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)  
CLADOSIPHON OKAMURANUS (UNII: 2IJE0CH09J)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SQUALANE (UNII: GW89575KF9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALLANTOIN (UNII: 344S277G0Z)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4479-1150000 mL in 1 DRUM; Type 0: Not a Combination Product03/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/16/2022
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4479)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4479) , manufacture(63931-4479) , pack(63931-4479)

Revised: 3/2022
Document Id: da577c26-1652-08f5-e053-2995a90a247d
Set id: da578723-ae4b-6c90-e053-2995a90a65c7
Version: 1
Effective Time: 20220316
 
Nanophase Technologies Corporation