DR.JART PREMIUM BEAUTY BALM 02 MEDIUM DEEP (OCTINOXATE, OCTISALATE) CREAM [HAVE & BE CO., LTD.]

  • Home
  • DR.JART PREMIUM BEAUTY BALM 02 MEDIUM DEEP (OCTINOXATE, OCTISALATE) CREAM [HAVE & BE CO., LTD.]

DR.JART PREMIUM BEAUTY BALM 02 MEDIUM DEEP (OCTINOXATE, OCTISALATE) CREAM [HAVE & BE CO., LTD.]
PDF | XML
NDC 49404-138-01, 49404-138-02
Set ID 7afc2570-030e-4749-9297-9501d9a1c707
Category HUMAN OTC DRUG LABEL
Packager Have & Be Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
View All Sections
  • ACTIVE INGREDIENT

    Titanium Dioxide 7.96%

    Octinoxate 6.79%

    Zinc Oxide 5.00%

    Octisalate 4.50%

  • 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
    CYCLOHEXASILOXANE
    GLYCERIN
    PEG-10 DIMETHICONE
    NIACINAMIDE
    C12-15 ALKYL BENZOATE
    DIPHENYLSILOXY PHENYL TRIMETHICONE
    DIPROPYLENE GLYCOL
    HEXYL LAURATE
    IRON OXIDES(CI 77492)
    TALC
    DISTEARDIMONIUM HECTORITE
    MAGNESIUM SULFATE
    DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER
    DIMETHICONE
    TRIETHOXYCAPRYLYLSILANE
    IRON OXIDES(CI 77491)
    PHENOXYETHANOL
    IRON OXIDES(CI 77499)
    METHICONE
    POLYGLYCERYL-6 POLYRICINOLEATE
    ETHYLHEXYLGLYCERIN
    TRIHYDROXYSTEARIN
    ADENOSINE
    CITRUS AURANTIUM DULCIS (ORANGE) PEELOIL
    PINUS SYLVESTRIS LEAF OIL
    CITRUS AURANTIFOLIA (LIME) OIL
    BHT
    EUCALYPTUS GLOBULUS LEAF OIL
    CITRUS LIMON (LEMON) PEEL OIL
    CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL
    ALLANTOIN
    1,2-HEXANEDIOL
    PALMITOYL TRIPEPTIDE-5
    PLATINUM POWDER
    PALMITOYL HEXAPEPTIDE-12
    POLYSORBATE 80

  • 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 PREMIUM BEAUTY BALM 02 MEDIUM DEEP 
    octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-138
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.716 mg  in 40 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 mg  in 40 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.8 mg  in 40 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.18 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TALC (UNII: 7SEV7J4R1U)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ADENOSINE (UNII: K72T3FS567)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    LIME OIL (UNII: UZH29XGA8G)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LEMON OIL (UNII: I9GRO824LL)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PLATINUM (UNII: 49DFR088MY)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49404-138-021 in 1 CARTON07/20/2020
    1NDC:49404-138-0140 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 finalpart35201/08/2018
    Labeler - Have & Be Co., Ltd. (690400408)
    Registrant - Have & Be Co., Ltd. (690400408)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(49404-138)
View All Sections

Related Drugs

Search DailyMed Drugs