WL-AAB-Z-W-404- 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-404

WL-AAB-Z-W-404

GHS Label

WL-AAB-Z-W-404 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4532
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
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
ALLANTOIN (UNII: 344S277G0Z)  
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)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4532-1150000 mL in 1 DRUM; Type 0: Not a Combination Product08/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/02/2022
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4532)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4532) , manufacture(63931-4532) , pack(63931-4532)

Revised: 8/2022
Document Id: e54775c9-66d5-60e2-e053-2a95a90a8541
Set id: e54769bf-8568-7f61-e053-2a95a90a3f08
Version: 1
Effective Time: 20220802
 
Nanophase Technologies Corporation