WL-AAB-Z-W-780- 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-780

WL-AAB-Z-W-780

Label-GHS

WL-AAB-Z-W-780 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4355
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE134.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ALLANTOIN (UNII: 344S277G0Z)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ISODODECANE (UNII: A8289P68Y2)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4355-1150000 mL in 1 DRUM; Type 0: Not a Combination Product03/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2019
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4355)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4355) , manufacture(63931-4355) , pack(63931-4355)

Revised: 1/2022
Document Id: d5c82eaf-9d78-e63c-e053-2995a90a33d6
Set id: 9edf2875-bff1-c09d-e053-2a95a90a4c7b
Version: 2
Effective Time: 20220117
 
Nanophase Technologies Corporation