WATERFUL ESSENCE SUN (OCTINOXATE, HOMOSALATE, OCTISALATE) CREAM [BMONUMENT CO., LTD]

WATERFUL ESSENCE SUN (OCTINOXATE, HOMOSALATE, OCTISALATE) CREAM [BMONUMENT CO., LTD]
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NDC 72293-0001-1
Set ID 6b590c72-124d-6f45-e053-2991aa0a8af6
Category HUMAN OTC DRUG LABEL
Packager BMONUMENT Co., Ltd
Generic Name
Product Class Adenosine Receptor Agonist
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Ethylhexyl Methoxycinnamate, Homosalate, Ethyhexyl Salicylate, Niacinamide, Adenosine

  • INACTIVE INGREDIENT

    Water, etc

  • PURPOSE

    • Sunscreen
    • Whitening
    • Anti-Wrinkle
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • WARNINGS

    1. In case of getting red spots, inflation or itching side-effects while or after using the products
    contact a doctor right away.
    2. Do not use on damaged or broken skin.
    3. Handling and storage precautions
    (1) Keep out of reach of children
    (2) Keep away from direcct sunlight

  • INDICATIONS & USAGE

    Apply a small amount of cream on the face and gently pat the skin at the last stage of skincare.

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    WATERFUL ESSENCE SUN 
    octinoxate, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72293-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72293-0001-150 mL in 1 TUBE; Type 0: Not a Combination Product05/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/04/2018
    Labeler - BMONUMENT Co., Ltd (694624625)
    Registrant - BMONUMENT Co., Ltd (694624625)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(72293-0001) , label(72293-0001) , pack(72293-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMONUMENT Co., Ltd694624625relabel(72293-0001)

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