EASYDEW EX FRESH MILD SUNSCREEN SPF50 PLUS PA PLUS PLUS PLUS (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, OCTOCRYLENE) CREAM [DN COMPANY CO., LTD.]

EASYDEW EX FRESH MILD SUNSCREEN SPF50 PLUS PA PLUS PLUS PLUS (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, OCTOCRYLENE) CREAM [DN COMPANY CO., LTD.]
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NDC 60565-050-01
Set ID 7970f5ca-a23a-43f4-b571-f860eac5ddab
Category HUMAN OTC DRUG LABEL
Packager DN Company Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 4.25%, Ethylhexyl Salicylate 2%, Octocrylene 2%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Ethylhexyl Palmitate, Cyclopentasiloxane,4-Methylbenzylidene Camphor, Butylene Glycol, Butyl Methoxydibenzoylmethane, Dipropylene Glycol, Cetearyl Alcohol, Beeswax, Glyceryl Stearate, Polysorbate 60, PEG-100 Stearate, Glycol Stearate, Triceteareth-4 Phosphate, Silica, Potassium Cetyl Phosphate, Methyl Methacrylate Crosspolymer, Isoamyl Laurate, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Caprylate, Caprylyl Glycol, Dimethicone, Caprylic/Capric Triglyceride, Saccharide Isomerate, Hydrogenated Lecithin, Sodium Ascorbyl Phosphate, sh-Oligopeptide-1, Alcohol Denat., Xanthan Gum, BHT, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum)

  • 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 FRESH MILD SUNSCREEN  SPF50 PLUS PA PLUS PLUS PLUS
    octinoxate, titanium dioxide, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60565-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3 mg  in 40 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.7 mg  in 40 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.8 mg  in 40 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.8 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60565-050-0140 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(60565-050)

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