Label: BELUCIE LUXURY TIMELESS GOLDEN AGE NIGHT- dimethicone cream 

  • Label RSS
  • NDC Code(s): 50410-070-01
  • 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

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  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 1%

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  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Aloe Barbadensis Leaf Extract, Glycerin, Butylene Glycol, Dipropylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Hydrogenated Poly(C6-14 Olefin), Octyldodecyl Myristate, Caprylic/Capric Triglyceride, Niacinamide, Stearyl Alcohol, Glyceryl Stearate SE, Glyceryl Stearate, PEG-100 Stearate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-3 Methylglucose Distearate, Water, Diisostearyl Malate, Sorbitan Stearate, C14-22 Alcohols, C12-20 Alkyl Glucoside, Mica (CI 77019), Titanium Dioxide (CI 77891), Ammonium Acryloyldimethyltaurate/VP Copolymer, Methylparaben, Phenoxyethanol, Fragrance(Parfum), Dipotassium Glycyrrhizate, Propylparaben, Triethanolamine, Silica, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine, Disodium EDTA, Lecithin, Alcohol, Argania Spinosa Kernel Extract, Butylparaben, Ethylparaben, Isobutylparaben, Polysorbate 80, Saccharomyces/Xylinum/Black Tea Ferment, Sodium Polyacrylate, Propylene Glycol, PVM/MA Copolymer, Iron Oxides (CI 77491), Gold, Caviar Extract, Sigesbeckia Orientalis Extract, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Yellow 6, Rabdosia Rubescens Extract, Sodium Cocoyl Glutamate, Carbomer, Sodium Ascorbyl Phosphate, Hydroxyethylcellulose, 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 emulsion, spread gently suitable amount depending on the skin texture.

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  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    BELUCIE LUXURY TIMELESS GOLDEN AGE NIGHT 
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50410-070
    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  
    Butylene Glycol  
    Dipropylene Glycol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50410-070-01 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(50410-070)
    Establishment
    Name Address ID/FEI Business Operations
    COSMAX INC. 689019313 manufacture(50410-070)
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