WL-AAB-Z-W-403- 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-403

WL-AAB-Z-W-403

GHS Label

WL-AAB-Z-W-403 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4486
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALLANTOIN (UNII: 344S277G0Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-TOCOPHEROL (UNII: 9U6A490501)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4486-1150000 mL in 1 DRUM; Type 0: Not a Combination Product03/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/23/2022
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4486)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4486) , manufacture(63931-4486) , pack(63931-4486)

Revised: 2/2023
Document Id: f4b16616-5ed7-65db-e053-2995a90a7efe
Set id: f4b1880e-f3bb-ab62-e053-2995a90a4740
Version: 1
Effective Time: 20230214
 
Nanophase Technologies Corporation