Label: WL-AAE-ZT-O-492- titanium dioxide, zinc oxide lotion
- NDC Code(s): 63931-4314-1
- Packager: Nanophase Technologies Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 10, 2023
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- WL-AAE-ZT-O-492
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INGREDIENTS AND APPEARANCE
WL-AAE-ZT-O-492
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4314 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 22 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 11 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color white (Lotion) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4314-1 150000 mL in 1 DRUM; Type 0: Not a Combination Product 04/03/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/03/2019 Labeler - Nanophase Technologies Corporation (623502044)
