Label: WL-AAE-ZT-O-1337- titanium dioxide, zinc oxide lotion
- NDC Code(s): 63931-4518-1
- 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 February 23, 2022
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- WL-AAE-ZT-O-1337
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INGREDIENTS AND APPEARANCE
WL-AAE-ZT-O-1337
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4518 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 19.4 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM) RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT) 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) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 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) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4518-1 150000 mL in 1 DRUM; Type 0: Not a Combination Product 02/23/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/23/2022 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Corporation (623502044)
