WL-AAB-Z-W-1117- 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-1117

WL-AAB-Z-W-1117

GHS label (Bulk)

WL-AAB-Z-W-1117 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4463
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
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)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
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)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4463-1150000 mL in 1 DRUM; Type 0: Not a Combination Product05/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/24/2021
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4463)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4463) , manufacture(63931-4463) , pack(63931-4463)
Establishment
NameAddressID/FEIBusiness Operations
Amcol Health & Beauty Solutions872684803api manufacture(63931-4463)

Revised: 9/2021
Document Id: cbdfc922-6ec7-4dda-e053-2995a90aaa71
Set id: cbdfaed5-d2e1-711c-e053-2a95a90a5150
Version: 1
Effective Time: 20210913
 
Nanophase Technologies Corporation