Label: BELUCIE LUXURY TIMELESS GOLDEN AGE DAY- dimethicone cream

  • NDC Code(s): 50410-060-01
  • Packager: KIMJEONGMOON ALOE CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 1%

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  • 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

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  • PURPOSE

    Purpose: Skin Protectant

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  • 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

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • INDICATIONS AND USAGE

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

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  • DOSAGE AND ADMINISTRATION

    Dosage and administration
    After using skin, spread gently ease the amount depending on the skin texture

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  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    BELUCIE LUXURY TIMELESS GOLDEN AGE DAY 
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50410-060
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (DIMETHICONE) DIMETHICONE 0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    Glycerin  
    Niacinamide  
    Butylene Glycol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50410-060-01 50 mL in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 06/01/2012
    Labeler - KIMJEONGMOON ALOE CO., LTD. (689253722)
    Registrant - KIMJEONGMOON ALOE CO., LTD. (689253722)
    Establishment
    Name Address ID/FEI Business Operations
    KIMJEONGMOON ALOE CO., LTD. 689253722 repack(50410-060)
    Establishment
    Name Address ID/FEI Business Operations
    COSMAX INC. 689019313 manufacture(50410-060)
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