WL-AAJ-Z-W-818- 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-AAJ-Z-W-818

WL-AAJ-Z-W-818

GHS label (Bulk)

WL-AAJ-Z-W-818 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4416
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
SQUALANE (UNII: GW89575KF9)  
PROPANEDIOL (UNII: 5965N8W85T)  
WATER (UNII: 059QF0KO0R)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYESTER-7 (UNII: 0841698D2F)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STANNOUS OXIDE (UNII: JB2MV9I3LS)  
MICA (UNII: V8A1AW0880)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4416-1160000000 mL in 1 DRUM; Type 0: Not a Combination Product06/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/10/2021
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Cirporation (623502044)

Revised: 9/2021
Document Id: cc31bea3-76ce-00e4-e053-2995a90ad4e4
Set id: cc31a001-4fad-223f-e053-2995a90a2c77
Version: 1
Effective Time: 20210917
 
Nanophase Technologies Corporation