WL-AAB-Z-W-1118- 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-1118

WL-AAB-Z-W-1118

GHS label (Bulk)

WL-AAB-Z-W-1118 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4464
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE135.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
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)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
MICA (UNII: V8A1AW0880)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4464-1150000 mL in 1 DRUM; Type 0: Not a Combination Product06/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/27/2021
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4464)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4464) , manufacture(63931-4464) , pack(63931-4464)
Establishment
NameAddressID/FEIBusiness Operations
Amcol Health & Beauty Solutions872684803api manufacture(63931-4464)

Revised: 9/2021
Document Id: cbe081fc-3ede-189b-e053-2a95a90ac74c
Set id: cbe081fc-3edd-189b-e053-2a95a90ac74c
Version: 1
Effective Time: 20210913
 
Nanophase Technologies Corporation