Label: INVINCIBLE SETTING POWDER SPF 45- titanium dioxide, zinc oxide powder

  • 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 January 13, 2017

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  • ACTIVE INGREDIENT

    Active ingredients                 Purpose

    Titanium Dioxide 15.7%        Sunscreen

    Zinc Oxide 20%                    Sunscreen

  • PURPOSE

    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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    Warnings For external use only

    Do not on damaged or broken skin

    When using this product keep out of eyes

    Rinse with water to remove

    If swallowed, get medical help or contact a Poison Center right away

  • DOSAGE & ADMINISTRATION

    Directions ​Apply liberally and evenly to face before sun exposure 

    Reapply after 40 minutes of swimming or sweating

    immediately after towel drying

    at least every 2 hours

    Children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients  ​Silica, Calcium Aluminum Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Phenoxyethanol,  Water (Aqua), Sodium Dehydroacetate, Ascorbyl palmitate, Ceteareth-25, Glycerin, Cetyl Alcohol, Cholesterol, Ceramide NP, Behenic Acid, Ethylhexyglycerin, Ceramide NS, Ceramide AP, Ceramide EOP, Ceramide EOS, Caprooyl Pytosphingosine, Caprooyl Sphingosine, Tocopherol, Titanium Dioxide (CI77891), Iron Oxides (CI 77491)

  • PRINCIPAL DISPLAY PANEL

    Invincible Setting Powder

    SPF 45

    100% mineral. Sweat Resistant

    0.09 oz / 2.5 g

    outer

    jar

  • INGREDIENTS AND APPEARANCE
    INVINCIBLE SETTING POWDER SPF 45 
    titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE15.7 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CERAMIDE NP (UNII: 4370DF050B)  
    BEHENIC ACID (UNII: H390488X0A)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    Ceramide AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-105-014.5 g in 1 PACKAGE; Type 0: Not a Combination Product01/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/13/2017
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Laboratories, Inc.001535103manufacture(75936-105)
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