EASYDEW EX MINERAL BB SPF45 PA PLUS PLUS (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) CREAM [DN COMPANY CO., LTD.]

EASYDEW EX MINERAL BB SPF45 PA PLUS PLUS (TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE) CREAM [DN COMPANY CO., LTD.]
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NDC 60565-040-01
Set ID 99fe1885-8ef5-4e69-9617-6ffdb01a0c35
Category HUMAN OTC DRUG LABEL
Packager DN Company Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients: Titanium Dioxide 9.94%, Ethylhexyl Methoxycinnamate 7%, Zinc Oxide 2.94%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, PEG-10 Dimethicone, Dicaprylyl Carbonate, Butylene Glycol, Arbutin, Sodium Chloride, Rosa Canina Fruit Oil, Avena Sativa (Oat) Kernel Extract, Amethyst Powder, Pearl Powder, Tourmaline, Brassica Oleracea Italica (Broccoli) Sprout Extract, Zea Mays (Corn) Leaf Extract, Triticum Aestivum (Wheat) Leaf Extract, Hydrolyzed Coral, Phenyl Trimethicone, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Sesquioleate, Isoamyl p-Methoxycinnamate, Dimethicone, Glyceryl Behenate/Eicosadioate, Caprylic/Capric Glycerides, Ethylhexylglycerin, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Adenosine, Hydrogenated Lecithin, Potassium Cetyl Phosphate, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Alcohol Denat., BHT, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

  • PURPOSE

    Purpose: Sunscreen

  • 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 dermatologist
    - In case of having problems such as red rash, swollenness, itching, stimulation during usage.
    - 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of babies and children

  • INDICATIONS AND USAGE

    Indications and usage:
    Tighten the lid after using it.
    Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration:
    In the morning at the end of your daily skin care routine, take an appropriate amount and apply to your entire face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    EASYDEW EX MINERAL BB  SPF45 PA PLUS PLUS
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60565-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.97 mg  in 40 mL
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.8 mg  in 40 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.17 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60565-040-0140 mL in 1 CARTON; Type 0: Not a Combination Product07/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2013
    Labeler - DN Company Co., Ltd. (688369859)
    Registrant - DN Company Co., Ltd. (688369859)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60565-040)

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