WL-AAE-ZT-O-492- 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.

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WL-AAE-ZT-O-492 (bulk-SVENS Sunscreen)

WL-AAE-ZT-O-492

WL-AAE-ZT-O-492

WL-AAE-ZT-O-492 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4314
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE22 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
STEARETH-20 (UNII: L0Q8IK9E08)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
ALLANTOIN (UNII: 344S277G0Z)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
POLYESTER-7 (UNII: 0841698D2F)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
SQUALANE (UNII: GW89575KF9)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
Product Characteristics
Colorwhite (Lotion) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4314-1150000 mL in 1 DRUM; Type 0: Not a Combination Product04/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/03/2019
Labeler - Nanophase Technologies Corporation (623502044)

Revised: 1/2023
Document Id: f1ecfcdd-62fc-67ce-e053-2995a90a0eb8
Set id: 86e916cc-4576-d6a5-e053-2991aa0afb9e
Version: 2
Effective Time: 20230110
 
Nanophase Technologies Corporation