Label: DR.JART DIS-A-PORE BEAUTY BALM 02- titanium dioxide, octinoxate, octisalate cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 20, 2024

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  • ACTIVE INGREDIENT

    Titanium Dioxide 15.97%

    Octinoxate 4.99%

    Octisalate 3.00%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

    If used as directed with other sun protection meausres (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun

  • DOSAGE & ADMINISTRATION

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours.
    • 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 value of 15 or higher and other sun protection measures including: 

    – Limit time in the sun, especially from 10 am - 2 pm

    – Wear long-sleeved shirts, pants, hats and
    sunglasses

    • Children under 6 months: Ask a doctor

  • WARNINGS

    For external use only.
    Do not use on damaged or broken skin.
    When using this product, keep out of eyes. Rinse with water to remove.
    Stop using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    WATER, CYCLOPENTASILOXANE, DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER, ISODODECANE, LAURYL PEG-10TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE, DIMETHICONE, NIACINAMIDE, METHYLPROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, IRON OXIDES(CI 77492), DISTEARDIMONIUM HECTORITE, GLYCERIN, MAGNESIUM SULFATE, ISOPROPYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONECROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES(CI 77491), DIPENTAERYTHRITYLHEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINUM HYDROXIDE, IRON OXIDES(CI 77499), CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, PINUS SYLVESTRIS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL, SILICA, ADENOSINE, SYNTHETIC FLUORPHLOGOPITE, BHT, TOCOPHEROL, BUTYLENE GLYCOL, ALCOHOL, 1,2-HEXANEDIOL, LECITHIN, PISTACIA LENTISCUS (MASTIC) GUM

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sunlight.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DR.JART DIS-A-PORE BEAUTY BALM 02 
    titanium dioxide, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-146
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.388 mg  in 40 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.996 mg  in 40 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.2 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49404-146-021 in 1 CARTON11/07/2019
    140 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/07/2019
    Labeler - Have & Be Co., Ltd. (690400408)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.963271750manufacture(49404-146)