Label: BELUCIE LUXURY TIMELESS GOLDEN AGE EYE- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 29, 2012

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

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 5%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Aloe Barbadensis Leaf Extract, Butylene Glycol, Hydrogenated Poly(C6-14 Olefin),Macadamia Integrifolia Seed Oil,Cetyl Ethylhexanoate,Glyceryl Stearate,Butyrospermum Parkii (Shea) Butter,PEG-100 Stearate,Bis-Diglyceryl Polyacyladipate-2,Niacinamide,Cetearyl Alcohol,Sorbitol,Water,Methylparaben,Fragrance(Parfum), Phenoxyethanol,Propylparaben,BHT,Tocopheryl Acetate,Adenosine,Triethanolamine,Carbomer,Lecithin,Alcohol, Butylparaben,Ethylparaben,Isobutylparaben,Glycerin,Disodium EDTA,Caramel,Polysorbate 80,Vitis Vinifera (Grape) Seed Oil,Saccharomyces/Xylinum/Black Tea Ferment,Caprylic/Capric Triglyceride,Argania Spinosa Kernel Extract,Yellow 6 (CI 15985),Yellow 5 (CI 19140),Sigesbeckia Orientalis Extract,Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane,Tremella fuciformis Sporocarp Extract,Rabdosia Rubescens Extract,Hydroxyethylcellulose,
    Sodium Ascorbyl Phosphate,Caviar Extract,Sodium Cocoyl Glutamate,Potassium Sorbate,Platinum Powder

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings
    1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dematologists.
    2. In case of having problems such as red spots, swelling, itching and irritation during usage
    3. In case the above symptoms emerge due to direct exposure to sunlight
    4. Please do not apply the skin to areas affected by eczema and dermatitis

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS AND USAGE

    Indication and usage
    1. Recap the bottle after use.
    2. Avoid exposure to a high or low temperature of direct sunlight

  • DOSAGE AND ADMINISTRATION

    Dosage and administration
    Spread gently around eye to take out suitable amount and tap with your finger lightly

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BELUCIE LUXURY TIMELESS GOLDEN AGE EYE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50410-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.5 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Cetyl Ethylhexanoate (UNII: 134647WMX4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50410-050-0130 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2012
    Labeler - KIMJEONGMOON ALOE CO., LTD. (689253722)
    Registrant - KIMJEONGMOON ALOE CO., LTD. (689253722)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIMJEONGMOON ALOE CO., LTD.689253722repack(50410-050)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX INC.689019313manufacture(50410-050)