Label: DOMINAS DARK SPOT UV DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

  • NDC Code(s): 72330-301-50, 72330-301-52
  • Packager: fmg Co.Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 13, 2024

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

  • ACTIVE INGREDIENTS

    Avobenzone 2.7%
    Homosalate 9.0%
    Octisalate 4.5%
    Octocrylene 9.0%

  • PURPOSE

    Sunscreen

  • 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
  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use​on damaged or broken skin

  • WHEN USING

    When using this productkeep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask doctorif rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • apply liberally 15 minutes before sun exposure
    • children under 6 months: Ask a doctor
    • reapply at least every 2 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

  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, ISODODECANE, POTASSIUM CETYL PHOSPHATE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, 1,2-HEXANEDIOL, BENZOTRIAZOLYL DODECYL P-CRESOL, PANTHENOL, GLYCERYL CAPRYLATE, GLYCERYL STEARATE, NIACINAMIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, MAGNESIUM ALUMINUM SILICATE, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, FRAGRANCE, SORBITAN OLIVATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, XANTHAN GUM, DIPROPYLENE GLYCOL, TROMETHAMINE,
    TRISODIUM EDTA, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, PAEONOL, PAEONIA SUFFRUTICOSA BRANCH/FLOWER/LEAF EXTRAC

  • OTHER INFORMATION

    • protect the product in this container from excessive heat and direct sun
    • the product may stain certain types of fabrics
  • QUESTIONS?

    1-866-993-4709

  • PRINCIPAL DISPLAY PANEL 50ml / 1.7 fl. oz Tube Carton

    DOMINAS

    DARK SPOT
    UV DEFENSE
    SUNSCREEN

    BROAD SPECTRUM SPF 50

    + DERMATOLOGICALLY TESTED
    + VITAMIN B3

    50 ml / 1.7 fl. oz

    + Dermatologically tested
    + Formulated without PABA
    + Fomulated without ethanol
    + Sheer & Lightweight Formula

    MADE IN KOREA
    DISTR. LG H&H Co., Ltd.
    58, SAEMUNAN-RO, JONGNO-GU,
    SEOUL, KOREA

    Dominas Dark Spot UV Defense Sunscreen SPF50 50ml IC

    Dominas Dark Spot UV Defense Sunscreen SPF50 50ml OC

  • PRINCIPAL DISPLAY PANEL 50ml / 1.7 fl. oz x 2 ea

    DOMINAS

    DARK SPOT
    UV DEFENSE
    SUNSCREEN

    BROAD SPECTRUM SPF 50

    + DERMATOLOGICALLY TESTED
    + VITAMIN B3

    50 ml / 1.7 fl. oz x 2 ea

    + Dermatologically tested
    + Formulated without PABA
    + Fomulated without ethanol
    + Sheer & Lightweight Formula

    MADE IN KOREA
    DISTR. LG H&H Co., Ltd.
    58, SAEMUNAN-RO, JONGNO-GU,
    SEOUL, KOREA

    dominas_dark_spot_uv_defense_sunscreen_spf50_2ea

  • INGREDIENTS AND APPEARANCE
    DOMINAS DARK SPOT UV DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72330-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.7 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72330-301-501 in 1 CARTON10/30/2023
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:72330-301-522 in 1 CARTON05/01/2024
    250 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/30/2023
    Labeler - fmg Co.Ltd (690188305)
    Registrant - LG H&H Co.,Ltd. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    fmg Co.Ltd690188305manufacture(72330-301)