DR.JART BLACK LABEL DETOX BEAUTY BALM (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [HAVE & BE CO., LTD.]

DR.JART BLACK LABEL DETOX BEAUTY BALM (TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [HAVE & BE CO., LTD.]
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NDC 49404-139-01, 49404-139-02
Set ID 4e2cb35e-e54a-402d-bb1b-4c3e7f684ddd
Category HUMAN OTC DRUG LABEL
Packager Have & Be Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Titanium Dioxide 8.32%

    Octinoxate 6.00%

    Octisalate 2.00%

    Zinc Oxide 1.96%

  • 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
    PHENYL TRIMETHICONE
    METHYLPROPANEDIOL
    CAPRYLIC/CAPRIC TRIGLYCERIDE
    CYCLOMETHICONE
    GLYCERIN
    LAURYL PEG-10TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE
    NIACINAMID

    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
    DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER
    PENTYLENE GLYCOL
    DISTEARDIMONIUM HECTORITE
    DIISOSTEARYL MALATE
    ISOEICOSANE
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYLDIMETHICONE
    SYNTHETIC FLUORPHLOGOPITE
    MAGNESIUM SULFATE
    IRON OXIDES(CI 77492)
    SILICA DIMETHYL SILYLATE
    ACRYLATES/DIMETHICONE COPOLYMER
    TRIETHOXYCAPRYLYLSILANE
    ORYZA SATIVA (RICE) BRAN OIL
    VEGETABLE OIL
    IRON OXIDES(CI 77491)
    IRON OXIDES(CI 77499)
    CAPRYLYL GLYCOL
    GLYCERYL CAPRYLATE
    AMINOPROPYL DIMETHICONE
    RHUS SUCCEDANEA FRUIT WAX
    HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX
    ORYZA SATIVA (RICE) BRAN WAX
    POLYMETHYLSILSESQUIOXANE
    ETHYLHEXYLGLYCERIN
    TOCOPHERYL ACETATE
    ALUMINA
    ALUMINUM HYDROXIDE
    SILICA
    ADENOSINE
    CITRUS AURANTIUM DULCIS (ORANGE) PEELOIL
    DIMETHICONE
    SODIUM HYALURONATE
    PINUS SYLVESTRIS LEAF OIL
    CITRUS AURANTIFOLIA (LIME) OIL
    EUCALYPTUS GLOBULUS LEAF OIL
    TOCOPHEROL
    CITRUS LIMON (LEMON) PEEL OIL
    CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL
    ASCORBYL PALMITATE
    BUTYLENE GLYCOL
    CAMELLIA SINENSIS LEAF EXTRACT
    PORTULACA OLERACEA EXTRACT
    CYNARA SCOLYMUS (ARTICHOKE) LEAFEXTRACT
    ALOE BARBADENSIS LEAF EXTRACT
    1,2-HEXANEDIOL

  • OTHER SAFETY INFORMATION

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

    You may report a serious adverse event from use of this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DR.JART BLACK LABEL DETOX BEAUTY BALM 
    titanium dioxide, octinoxate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.328 mg  in 40 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.4 mg  in 40 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.784 mg  in 40 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.8 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    CORN OIL (UNII: 8470G57WFM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ADENOSINE (UNII: K72T3FS567)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49404-139-021 in 1 CARTON06/18/2019
    1NDC:49404-139-0140 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/02/2018
    Labeler - Have & Be Co., Ltd. (690400408)
    Registrant - Have & Be Co., Ltd. (690400408)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(49404-139)

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