Label: DR.JART PREMIUM BEAUTY BALM FAIR-LIGHT- zinc oxide, titanium dioxide, octinoxate, octisalate cream

  • NDC Code(s): 49404-148-01, 49404-148-02
  • Packager: Have & Be Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 25, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    OCTINOXATE 6.8%
    OCTISALATE 4.5%
    TITANIUM DIOXIDE 4.8%
    ZINC OXIDE 5.0%


  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • DOSAGE & ADMINISTRATION

    For sunscreen use:
    ■ apply liberally 15 minutes before sun exposure
    ■ reapply at least every two hours
    ■ use a water resistant sunscreen if swimming or sweating
    ■ 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 a.m. – 2 p.m.
    – wear long-sleeved shirts, pants, hats and sunglasses
    ■ children under 6 months of age: 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, TITANIUM DIOXIDE(CI 77891), PEG-10 DIMETHICONE, TALC, C12-15 ALKYL BENZOATE, HEXYL LAURATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, NIACINAMIDE, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, IRON OXIDES(CI 77491), METHICONE, IRON OXIDES(CI 77499), POLYGLYCERYL-6 POLYRICINOLEATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, ADENOSINE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, CITRUS AURANTIFOLIA (LIME) OIL, PINUS SYLVESTRIS LEAF OIL, BHT, EUCALYPTUS GLOBULUS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS LIMON (LEMON) PEEL OIL, TOCOPHEROL, ALLANTOIN, 1,2-HEXANEDIOL, PALMITOYL TRIPEPTIDE-5, POLYSORBATE 80, PLATINUM POWDER, PALMITOYL HEXAPEPTIDE-12

  • 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 PREMIUM BEAUTY BALM FAIR-LIGHT 
    zinc oxide, titanium dioxide, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-148
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.8 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.8 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    TALC (UNII: 7SEV7J4R1U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ADENOSINE (UNII: K72T3FS567)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PLATINUM (UNII: 49DFR088MY)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49404-148-021 in 1 CARTON04/25/2022
    1NDC:49404-148-0140 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/25/2022
    Labeler - Have & Be Co., Ltd. (690400408)
    Registrant - Have & Be Co., Ltd. (690400408)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(49404-148)