WL-AAJ-Z-W-508 (KOPARI 50ML)- 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-508 (Kopari 50ml)

WL-AAJ-Z-W-508 (Kopari) GHS Label

Label-GHS

WL-AAJ-Z-W-508 (KOPARI 50ML) 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
PROPANEDIOL (UNII: 5965N8W85T)  
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
TOCOPHEROL (UNII: R0ZB2556P8)  
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-BISABOLOL, (-)-EPI- (UNII: 37VB7WIC8L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
UBIQUINONE Q2 (UNII: I7T5V2W47R)  
ALLANTOIN (UNII: 344S277G0Z)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CITRULLUS LANATUS VAR. CITROIDES WHOLE (UNII: N1HQX01Z1T)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ISODECYL SALICYLATE (UNII: S7097PFP4C)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
HIBISCUS SABDARIFFA SEED OIL (UNII: G2X0304IX1)  
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)  
POLYESTER-7 (UNII: 0841698D2F)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4312-1328600 mL in 1 DRUM; Type 0: Not a Combination Product02/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/08/2019
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Cirporation (623502044)

Revised: 2/2019
Document Id: 826a1017-f8b3-cc0b-e053-2a91aa0a9553
Set id: 826a1017-f8b2-cc0b-e053-2a91aa0a9553
Version: 1
Effective Time: 20190221
 
Nanophase Technologies Corporation