SAEMMUL A CLEAN BB (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) CREAM [THE SAEM INTERNATIONAL CO., LTD.]

SAEMMUL A CLEAN BB (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) CREAM [THE SAEM INTERNATIONAL CO., LTD.]
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NDC 70341-619-01, 70341-619-02
Set ID 147f5ea2-f519-4d42-83c8-73e34d5585d5
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 7.92%, ETHYLHEXYL METHOXYCINNAMATE 3.00%, ZINC OXIDE 1.92%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Cyclopentasiloxane, Talc, Glycerin, Methylpropanediol, Cyclomethicone, PEG-10 Dimethicone, Hexyldecyl Myristoyl Methylaminopropionate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Betaine, Triethylhexanoin, Magnesium Sulfate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Glycosyl Trehalose, Iron Oxides(CI 77492), Phenoxyethanol, Acrylates/Dimethicone Copolymer, Hydrogenated Starch Hydrolysate, Methicone, Iron Oxides(CI 77491), Iron Oxides(CI 77499), Palmitic Acid, Ethylhexylglycerin, Portulaca Oleracea Extract, Tocopheryl Acetate, Fragrance, Aluminum Hydroxide, Aluminum Stearate, Dimethicone, Butylene Glycol, Madecassoside, Aloe Barbadensis Leaf Water, Prunus Armeniaca (Apricot) Kernel Oil, Rosa Centifolia Flower Water, Tilia Vulgaris Flower Extract, Betula Alba Juice, Aloe Barbadensis Leaf Extract, Althaea Rosea Flower Extract, Benzyl Alcohol, Dehydroacetic Acid, Disodium EDTA

  • 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 A CLEAN BB 
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-619
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.18 g  in 15 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.45 g  in 15 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.28 g  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70341-619-021 in 1 CARTON05/01/2018
    1NDC:70341-619-0115 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
    Kolmar Korea Co., Ltd.689512611manufacture(70341-619)

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