WL-AAE-ZT-O-391- titanium dioxide, 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.

----------

WL-AAE-ZT-O-391

WL-AAE-ZT-O-391

GHS Label

WL-AAE-ZT-O-391 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-0391
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.7 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE19.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
POLYESTER-7 (UNII: 0841698D2F)  
GLYCERIN (UNII: PDC6A3C0OX)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALLANTOIN (UNII: 344S277G0Z)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARETH-20 (UNII: L0Q8IK9E08)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
SODIUM ASCORBATE (UNII: S033EH8359)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SQUALANE (UNII: GW89575KF9)  
PEG-75 STEARATE (UNII: OT38R0N74H)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
CETETH-20 (UNII: I835H2IHHX)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-0391-1150000 mL in 1 DRUM; Type 0: Not a Combination Product10/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/16/2018
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)

Revised: 2/2023
Document Id: f4be3e92-fbf5-1581-e053-2a95a90ab164
Set id: f4be3cb8-7016-1b65-e053-2995a90a3955
Version: 1
Effective Time: 20230215
 
Nanophase Technologies Corporation