Label: TOPIX MINERAL BRIGHTENING AND CORRECTING EYE MAKE-UP SPF 50- zinc oxide and titanium dioxide lotion
- NDC Code(s): 51326-121-01
- Packager: Topiderm, Inc.
- 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 March 17, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
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Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & other sunscreen measures including:
- Limit time in the sun especially from 10 a.m. to 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months of age: Ask a doctor.
- Other information
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Inactive Ingredients
Purified Water, Caprylyl Methicone, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Dimethicone Crosspolymer, Glycerin, Isododecane, Dimethicone, Alumina, Hydrogen Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides, Tin Oxide, Sodium Hyaluronate, Acetyl Hexapeptide-8, Leontopodium Alpinum Callus Culture Extract, Dunaliella Salina Extract, Macrocystis Pyrifera (Kelp) Extract, Panthenol, Tocopheryl Acetate, Palmitoyl Tripeptide-5, Hydrolyzed Vegetable Protein, Ascophyllum Nodosum Extract, Asparagopsis Armata Extract, Sucrose, Xanthan Gum, Mica, Silica, PVP, Triethoxycaprylylsilane, Sorbitol, Phenyl Trimethicone, Sodium Chloride, Phenoxyethanol, Disodium EDTA, Potassium Sorbate.
- PRINCIPAL DISPLAY PANEL - 8.5 ml Tube Carton
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INGREDIENTS AND APPEARANCE
TOPIX MINERAL BRIGHTENING AND CORRECTING EYE MAKE-UP SPF 50
zinc oxide and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51326-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 65 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 64 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (3500 MM2/S) (UNII: KB7T6C99UP) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM OXIDE (UNII: LMI26O6933) FERROUS OXIDE (UNII: G7036X8B5H) STANNOUS OXIDE (UNII: JB2MV9I3LS) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I) DUNALIELLA SALINA (UNII: F4O1DKI9A6) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL) ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ) ASPARAGOPSIS ARMATA (UNII: 2936KN6I1G) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) MICA (UNII: V8A1AW0880) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLY(4-VINYLPYRIDINE-N-OXIDE) (UNII: 2I40HY84KZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SORBITOL (UNII: 506T60A25R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51326-121-01 8.5 mL in 1 TUBE; Type 0: Not a Combination Product 01/24/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/24/2021 Labeler - Topiderm, Inc. (049121643) Registrant - Topiderm, Inc. (049121643) Establishment Name Address ID/FEI Business Operations Topiderm, Inc. 049121643 MANUFACTURE(51326-121)
