WL-AAE-Z-O-1342- 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-AAE-Z-O-1342

WL-AAE-Z-O-1342

GHS label (Bulk)

WL-AAE-Z-O-1342 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4512
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
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERYL STEARATE/PEG-75 STEARATE (UNII: 6PSS3TQ3UY)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CETETH-20 (UNII: I835H2IHHX)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
SQUALANE (UNII: GW89575KF9)  
STEARETH-20 (UNII: L0Q8IK9E08)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4512-1150000 mL in 1 DRUM; Type 0: Not a Combination Product03/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/16/2022
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)

Revised: 3/2022
Document Id: da55e0ee-3aaa-4ba5-e053-2995a90adbf4
Set id: da55e0ee-3aa9-4ba5-e053-2995a90adbf4
Version: 1
Effective Time: 20220316
 
Nanophase Technologies Corporation