WL-AAE-ZT-O-1258- 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-1258

WL-AAE-ZT-O-1258

GHS label (Bulk)

WL-AAE-ZT-O-1258 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63931-4508
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE19.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM ASCORBATE (UNII: S033EH8359)  
TOCOPHEROL (UNII: R0ZB2556P8)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYESTER-7 (UNII: 0841698D2F)  
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALLANTOIN (UNII: 344S277G0Z)  
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CETETH-20 (UNII: I835H2IHHX)  
PEG-75 STEARATE (UNII: OT38R0N74H)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SQUALANE (UNII: GW89575KF9)  
STEARETH-20 (UNII: L0Q8IK9E08)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MICA (UNII: V8A1AW0880)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63931-4508-1150000 mL in 1 DRUM; Type 0: Not a Combination Product03/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/16/2022
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)

Revised: 3/2022
Document Id: da5c7713-d877-6863-e053-2995a90aaacb
Set id: da5c63cd-a535-2f58-e053-2a95a90a8520
Version: 1
Effective Time: 20220316
 
Nanophase Technologies Corporation