SAEMMUL COVER FOUNDATION 02 NATURAL BEIGE (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [THE SAEM INTERNATIONAL CO., LTD.]

SAEMMUL COVER FOUNDATION 02 NATURAL BEIGE (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [THE SAEM INTERNATIONAL CO., LTD.]
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NDC 70341-621-01, 70341-621-02
Set ID 66bf8b94-6978-4336-a544-4e6f42d6cb20
Category HUMAN OTC DRUG LABEL
Packager The Saem International Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: TITANIUM DIOXIDE 13.38%, ZINC OXIDE 1.44%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Cyclopentasiloxane, Dimethicone, Butylene Glycol, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Diethylhexyl Carbonate, Glycerin, Iron Oxides (CI 77492), Phenyl Trimethicone, PEG-10 Dimethicone, Alcohol Denat., Niacinamide, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG-10 Methyl Ether Dimethicone, Methyl Methacrylate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Talc, Iron Oxides (CI 77491), Disteardimonium Hectorite, 1,2-Hexanediol, Triethoxycaprylylsilane, Caprylyl Glycol, Triethyl Citrate, Fragrance, Iron Oxides (CI 77499), Tocopheryl Acetate, Disodium EDTA, Betula Platyphylla Japonica Juice, Hydrogen Dimethicone, Ethylhexylglycerin, Adenosine, Propylene Glycol, Ethoxydiglycol, Rosa Centifolia Flower Water, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Adansonia Digitata Seed Extract, Equisetum Arvense Extract, Olea Europaea (Olive) Leaf Extract, Sophora Japonica Flower Extract, Pentylene Glycol, Fructan, Nelumbo Nucifera Flower Water, Ceramide NP, Sodium Hyaluronate

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    For external use only

    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 dermatologist.

    1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.

    2) In case of having the same symptoms above on the part you put this product on by direct sunlight.

    2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.

    3. In case of getting it into your eyes, you have to wash it immediately.

    4. Keep out of reach of babies and children.

  • DESCRIPTION

    Uses:

    Helps prevent sunburn.

    Directions:

    Use after your skincare routine. Apply an appropriate amount evenly on the face along skin's texture and gently tap for better coverage.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SAEMMUL COVER FOUNDATION 02 NATURAL BEIGE 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-621
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.00 g  in 15 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.21 g  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70341-621-021 in 1 CARTON05/01/2018
    1NDC:70341-621-0115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2018
    Labeler - The Saem International Co., Ltd. (689402402)
    Registrant - The Saem International Co., Ltd. (689402402)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca Korea Co., Ltd.688830827manufacture(70341-621)

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