UV MILD SUN BLOCK (OCTINOXATE) CREAM [COSON CO., LTD.]

UV MILD SUN BLOCK (OCTINOXATE) CREAM [COSON CO., LTD.]
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NDC 62171-020-01
Set ID 8ae9b5f1-050e-4a71-addd-0e578f797714
Category HUMAN OTC DRUG LABEL
Packager Coson Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    WATER, GLYCERIN, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DICAPRYLYL CARBONATE, ISOAMYL p-METHOXYCINNAMATE, GLYCERYL STEARATE, PEG-100 STEARATE, CETEARYL ALCOHOL, POLYSORBATE 60, CYCLOMETHICONE, TITANIUM DIOXIDE, SILICA, ALUMINA, STEARIC ACID, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, SORBITAN SESQUIOLEATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, TOCOPHERYL ACETATE, BETA GLUCAN, PORTULACA OLERACEA EXTRACT, ARNICA MONTANA FLOWER EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, GENTIANA LUTEA ROOT EXTRACT, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, DISODIUM EDTA, PHENOXYETHANOL, METHYL PARABEN, PROPYL PARABEN, FRAGRANCE

  • PURPOSE

    Purpose: UVA/UVB Protection

  • WARNINGS

    Warnings:
    1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.
    2. Do not use on scarred skin, or if you have dermatitis or eczema
    3. Keep the cap close on its product.
    4. Keep away from direct sunlight or heat.
    5. This product blocks UVA rays and ultraviolet protection effectiveness have been measured by the Food and Drug Administration methods and standards.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of babies and children

  • INDICATIONS AND USAGE

    Indication and Usage:
    At your final skin care step, apply it to your whole face with the proper amount after all your basic skin care.
    If you feel more perfect UV protect effect, apply it more whenever needed.

  • DOSAGE AND ADMINISTRATION

    Dosage and Administration:
    Release an appropriate amount and evenly spread over face and body with gentle patting.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    UV MILD SUN BLOCK 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62171-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62171-020-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2014
    Labeler - Coson Co., Ltd. (689835593)
    Registrant - Coson Co., Ltd. (689835593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coson Co., Ltd.689835593manufacture(62171-020)

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