WL-AAB-Z-W-1321- 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-1321

WL-AAB-Z-W-1321

GHS Label

WL-AAB-Z-W-1321 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4540
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
GLYCERIN (UNII: PDC6A3C0OX)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALLANTOIN (UNII: 344S277G0Z)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
TOCOPHEROL (UNII: R0ZB2556P8)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4540-1150000 mL in 1 DRUM; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/02/2022
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4540)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4540) , manufacture(63931-4540) , pack(63931-4540)

Revised: 2/2023
Document Id: f4b27385-f6d8-1c5c-e053-2a95a90a6a0c
Set id: f4b27679-0168-1d6d-e053-2995a90a0f7d
Version: 1
Effective Time: 20230214
 
Nanophase Technologies Corporation