Label: TOPIX MINERAL MATTIFYING TINTED SUNSCREEN SPF 50- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 22, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 20.5%

  • Purpose

    Sunscreen

  • 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

    For external use only.

    • When using this product keep out of eyes, rinse with water to remove.

    • Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

    • Keep out of reach of children.
    • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    • 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 and other sunscreen measures including:
      • limit time in the sun, especially from 10a.m.-2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
  • Directions

    • Apply liberally and spread evenly by hand 15 minutes before sun exposure
    • Re-apply after swimming, excessive perspiring, or anytime after towel drying
    • Use a water resistant sunscreen if swimming or sweating
    • Use on children under 6 months of age: consult a doctor.
  • Inactive ingredients

    Ascorbic Acid, Biotin, Camellia Sinensis (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Centella Asiatica Extract, Ceramide NG, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone, Glycerin, Hexyl Laurate, Iron Oxides, Isododecane, Methyl Trimethicone, PEG/PPG-18/18 Dimethicone, PEG-10 Dimethicone, PEG-8 Methyl Ether Triethoxysilane, Phospholipids, Phyllanthus Emblica Fruit Extract, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Purified Water, Resveratrol, Silica Dimethyl Silylate, Silica, Stearic Acid, Titanium Dioxide, Tocopheryl Acetate, Ubiquinone (Co-Enzyme Q10).

  • PRINCIPAL DISPLAY PANEL - 54 g Bottle Label

    COMPLIMENTS OF
    TOPIX
    PHARMACEUTICALS, INC

    MULTI-TASKING

    Mineral Mattifying
    Tinted Sunscreen
    SPF 50

    Broad Spectrum SPF 50

    Net wt. 1.9 oz. (54 g)

    Available
    Custom Branded
    800.445.2595
    c.service@topixpharm.com

    PRINCIPAL DISPLAY PANEL - 54 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    TOPIX MINERAL MATTIFYING TINTED SUNSCREEN   SPF 50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-137
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE205 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BIOTIN (UNII: 6SO6U10H04)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    ISODODECANE (UNII: A8289P68Y2)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    WATER (UNII: 059QF0KO0R)  
    RESVERATROL (UNII: Q369O8926L)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-137-0154 g in 1 BOTTLE; Type 0: Not a Combination Product11/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02011/15/2022
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-137)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals, Inc.117745066PACK(51326-137)
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