Label: ABALONE CRYSTALDOUBLE EX BB- octocrylene, niacinamide, adenosine, titanium dioxide, ethylhexyl methoxycinnamate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 10, 2017

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

  • ACTIVE INGREDIENT

    Niacinamide, Adenosine, Titanium Dioxide, Ethylhexyl Methoxycinnamate, Octocrylene

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Etc

  • PURPOSE

    Skin Protectant - Anti-Wrinkle, Whitening, UV Protecting

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    Use after your daily skincare routine
    Apply starting from larger surface using your fingertip, applying from the center and out, using less around the eyes and ridge of the nose
    For extra coverage, take a small amount of the product with the tip of your finger and dab over the affected area.
    *Always close the cover after each use. This prevents nourishing and moisturizing agents from evaporating.

  • WARNINGS

    1. Do not use in the following cases(Eczema and scalp wounds)
    2.Side Effects
    1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
    3.General Precautions
    1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    2)This product is for exeternal use only. Do not use for internal use
    4.Storage and handling precautions
    1)If possible, avoid direct sunlight and store in cool and area of low humidity
    2)In order to maintain the quality of the product and avoid misuse
    3)Avoid placing the product near fire and store out in reach of children

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ABALONE CRYSTALDOUBLE EX BB 
    octocrylene, niacinamide, adenosine, titanium dioxide, ethylhexyl methoxycinnamate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60611-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.9 g  in 100 mL
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60611-0009-135 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/10/2017
    Labeler - C&BCOSMETIC Co.,Ltd. (689909208)
    Registrant - C&BCOSMETIC Co.,Ltd. (689909208)
    Establishment
    NameAddressID/FEIBusiness Operations
    C&BCOSMETIC Co.,Ltd.689909208manufacture(60611-0009) , label(60611-0009) , pack(60611-0009)