Label: WL-AAE-ZT-O-1151- titanium dioxide, zinc oxide lotion
- NDC Code(s): 63931-4537-1
- Packager: Nanophase Technologies Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 14, 2023
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- WL-AAA-ZT-O-1151
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INGREDIENTS AND APPEARANCE
WL-AAE-ZT-O-1151
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4537 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9.7 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 19.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) 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) NIACINAMIDE (UNII: 25X51I8RD4) 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) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) KIGELIA AFRICANA FRUIT (UNII: L4J6XXD1E0) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) CETETH-20 (UNII: I835H2IHHX) HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741) PRUNUS DOMESTICA SUBSP. INSITITIA SEED OIL (UNII: VL2TFU9DZ5) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4537-1 150000 mL in 1 DRUM; Type 0: Not a Combination Product 05/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2022 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Corporation (623502044)
