Label: BELUCIE LUXURY SHINNING FOUNDATION BC- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 February 25, 2015

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  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide (CI 77891) 9.23%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Triethylhexanoin, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Pentylene Glycol, Sodium Chloride, Disteardimonium Hectorite, Iron Oxides (CI 77492), Cetyl Ethylhexanoate, Sorbitan Olivate, Sorbitan Isostearate, Talc, Trimethylsiloxysilicate, Phenoxyethanol, Iron Oxides (CI 77491), Glyceryl Behenate/Eicosadioate, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Aluminum Hydroxide, Dimethicone, Stearic Acid, Dimethicone Crosspolymer, Fragrance(Parfum), Ethylhexylglycerin, Disodium EDTA, Adenosine, Prunus Serrulata Flower Extract, Nymphaea Alba Flower Extract, Rosa Hybrid Flower Extract, Nelumbo Nucifera Flower Extract, Hydrogenated Castor Oil Isostearate, Argania Spinosa Kernel Oil, Butylene Glycol, Pearl Powder, Polyperfluoromethylisopropyl Ether, Polymethylsilsesquioxane, Aloe Barbadensis Leaf Extract, Potassium Sorbate, Punica Granatum Fruit Extract, Vinegar, Sigesbeckia Orientalis Extract, Rabdosia Rubescens Extract, Platinum Powder

  • PURPOSE

    Purpose: UVA/UVB Protection

  • 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 of 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 & USAGE

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

  • DOSAGE & ADMINISTRATION

    Dosage and administration: After suitable amount of pumping, tap lightly and spread carefully depending on your skin texture.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BELUCIE LUXURY SHINNING FOUNDATION BC 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50410-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.69 g  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50410-090-0140 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2015
    Labeler - Kimjeongmoon Aloe Co., Ltd. (689253722)
    Registrant - Kimjeongmoon Aloe Co., Ltd. (689253722)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kimjeongmoon Aloe Co., Ltd.689253722repack(50410-090)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX INC.689019313manufacture(50410-090)