Label: WL-AAI-ZT-P-522- titanium dioxide, zinc oxide powder
- NDC Code(s): 63931-4317-1
- 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-AAI-ZT-P-522
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INGREDIENTS AND APPEARANCE
WL-AAI-ZT-P-522
titanium dioxide, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4317 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.125 g in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.225 g in 1 g Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PROPANEDIOL (UNII: 5965N8W85T) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) NIACINAMIDE (UNII: 25X51I8RD4) ISODECYL SALICYLATE (UNII: S7097PFP4C) TOCOPHEROL (UNII: R0ZB2556P8) MICA (UNII: V8A1AW0880) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63931-4317-1 10000 g in 1 BAG; Type 0: Not a Combination Product 07/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/15/2019 Labeler - Nanophase Technologies Corporation (623502044) Registrant - Nanophase Technologies Corporation (623502044) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 050383046 api manufacture(63931-4317) Establishment Name Address ID/FEI Business Operations Nanophase Technologies Corporation 623502044 api manufacture(63931-4317) , manufacture(63931-4317) , pack(63931-4317)
