WL-AAB-Z-W-1001- 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-1001

WL-AAB-Z-W-1001 GHS Label

GHS label (Bulk)

WL-AAB-Z-W-1001 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4438
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)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MYRISTYL TRISILOXANE (UNII: J7960S4R1T)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ISODODECANE (UNII: A8289P68Y2)  
NIACINAMIDE (UNII: 25X51I8RD4)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
ISOCETETH-10 (UNII: 1K92T9919H)  
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
MICA (UNII: V8A1AW0880)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
ZEIN (UNII: 80N308T1NN)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4438-1150000 mL in 1 DRUM; Type 0: Not a Combination Product05/06/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/06/2021
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4438)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4438) , manufacture(63931-4438) , pack(63931-4438)
Establishment
NameAddressID/FEIBusiness Operations
Amcol Health & Beauty Solutions872684803api manufacture(63931-4438)

Revised: 9/2021
Document Id: cba6b8b4-f524-9c5f-e053-2995a90a15b0
Set id: cba6c5f6-104a-bb8c-e053-2a95a90a98c6
Version: 1
Effective Time: 20210910
 
Nanophase Technologies Corporation