Label: BELUCIE LUXURY TIMELESS GOLDEN AGE DAY- 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 30, 2012

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

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 1%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf Extract, Glycerin, Cyclopentasiloxane, Niacinamide, Cyclohexasiloxane, Butylene Glycol, Silica, Water, Carbomer, Triethanolamine, Polyacrylate-13, Dimethicone/Vinyl Dimethicone Crosspolymer, Methylparaben, Phenoxyethanol, Dimethiconol, Polysorbate 60, Polyisobutene, Fragrance(Parfum), Propylparaben, Allantoin, Adenosine, Butylparaben, Ethylparaben, Isobutylparaben, Glyceryl Polyacrylate, Polysorbate 20, Disodium EDTA, Lecithin, Alcohol, Saccharomyces/Xylinum/Black Tea Ferment, Polysorbate 80, Argania Spinosa Kernel Extract, Caprylic/Capric Triglyceride, Sigesbeckia Orientalis Extract, Sodium Hyaluronate, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Rabdosia Rubescens Extract, Hydroxyethylcellulose, Caviar Extract, Sodium Ascorbyl Phosphate, Red 4 , Yellow 5, 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
    After using skin, spread gently ease the amount depending on the skin texture

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BELUCIE LUXURY TIMELESS GOLDEN AGE DAY 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50410-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Niacinamide (UNII: 25X51I8RD4)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50410-060-0150 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(50410-060)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX INC.689019313manufacture(50410-060)