WL-AAN-Z-A-822- zinc oxide stick 
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-AAN-Z-A-822

WL-AAN-Z-A-822

GHS label (Bulk)

WL-AAN-Z-A-822 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4384
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE135 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
SQUALANE (UNII: GW89575KF9)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
NYLON-12 (UNII: 446U8J075B)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4384-1160000 g in 1 DRUM; Type 0: Not a Combination Product02/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2020
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4384)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4384) , manufacture(63931-4384) , pack(63931-4384)
Establishment
NameAddressID/FEIBusiness Operations
Amcol Health & Beauty Solutions872684803api manufacture(63931-4384)

Revised: 12/2021
Document Id: d3c1aae3-0ac7-1700-e053-2995a90ad286
Set id: d3c1aae3-0ac6-1700-e053-2995a90ad286
Version: 1
Effective Time: 20211222
 
Nanophase Technologies Corporation