VILLAGE11FACTORY DAILY MILD SUN (OCTINOXATE, HOMOSALATE, OCTISALATE) CREAM [PFD CO.,LTD.]

VILLAGE11FACTORY DAILY MILD SUN (OCTINOXATE, HOMOSALATE, OCTISALATE) CREAM [PFD CO.,LTD.]
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NDC 72470-010-01, 72470-010-02
Set ID e1f988a3-98b3-4e86-81eb-a089dfb14cfb
Category HUMAN OTC DRUG LABEL
Packager PFD Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 6.0%, Ethylhexyl Salicylate 4.5%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water,n Diethylamino Hydroxybenzoyl Hexyl Benzoate, Propanediol,Niacinamide, Cyclopentasiloxane,1,2-Hexanediol, Glyceryl Stearate, C12-15 Alkyl Benzoate,PEG-100 Stearate, Titanium Dioxide (CI77891), Salvia Hispanica Seed Extract, Centella Asiatica Extract,Houttuynia Cordata Extract, Polysorbate 60, AmmoniumAcryloyldimethyltaurate/VP Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methyl MethacrylateCrosspolymer, Squalane,Fructooligosaccharides, Saccharide Hydrolysate, Aluminum Stearate, Polyhydroxystearic Acid, Pullulan,Ethylhexylglycerin, Octyldodecanol, Portulaca Oleracea Extract, Adenosine, Alumina,Butylene Glycol, Disodium EDTA, SorbitanIsostearate, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower)Seed Oil Unsaponifiables, Tocopherol, Fragrance

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    1) In case of swelling, redness, itching or any severe allergic reactions while using the product, discontinue use and consult with a specialist.

    2) Do not apply on broken skin or wounded areas.

    3) Precautions for storage and handling A) Keep out of reach of children. B) Store away from direct sunlight.

    4) For external use only

  • DESCRIPTION

    Uses:

    Containing the UV suncare secret of village 11 factory, this daily mild sun cream is strong against UV rays but is gentle on the skin. Also, it helps to prevent sunburn.

    Directions:

    For the last step of your skin care, apply an appropriate amount onto areas of your skin that is exposed to sunlight.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    VILLAGE11FACTORY DAILY MILD SUN 
    octinoxate, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72470-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.50 g  in 50 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate3.00 g  in 50 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.25 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Niacinamide (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72470-010-021 in 1 CARTON07/01/2018
    1NDC:72470-010-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2018
    Labeler - PFD Co.,Ltd. (694522499)
    Registrant - PFD Co.,Ltd. (694522499)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coson Co., Ltd._Osan Plant689847210manufacture(72470-010)

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