Label: TOPIX MINERAL MATTIFYING TINTED SUNSCREEN SPF 30- zinc oxide cream

  • 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 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Zinc Oxide 16.5%Sunscreen
    Titanium Dioxide 3.2%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

    Alumina, Ascorbic Acid, Biotin, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis Leaf (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Centella Asiatica Extract, Ceramide NS, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone Crosspolymer, Dimethicone, Hexyl Laurate, Iron Oxides, Isodoecane, Methyl Trimethicone, PEG/PPG-18/18 Dimethicone, PEG-10 Dimethicone, PEG-8 Methyl Ether Triethoxysilane, Phospholipids, Phyllanthus Emblica Fruit Extract, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polymethylsilsesquiloxane, Polysilicone-11, Purified Water, Resveratrol, Silica Dimethyl Silylate, Silica, Stearic Acid, Tocopherol, Ubiquinone (Co-Enzyme Q10).

  • PRINCIPAL DISPLAY PANEL - 54 g Bottle Label

    COMPLIMENTS OF
    TOPIX
    PHARMACEUTICALS, INC

    MULTI-TASKING

    Mineral Mattifying
    Tinted Sunscreen
    SPF 30

    Broad Spectrum SPF 30

    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 30
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE162 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE32 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BIOTIN (UNII: 6SO6U10H04)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    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 (220 CST) (UNII: 287GF3Y3WC)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    WATER (UNII: 059QF0KO0R)  
    RESVERATROL (UNII: Q369O8926L)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    COENZYME Q10, (2Z)- (UNII: U705VLF0VW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-130-0154 g in 1 BOTTLE; Type 0: Not a Combination Product02/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/21/2023
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-130)
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