RED ORANGE SUN PACT SPF 50 PLUS PA PLUS PLUS PLUS (OCTINOXATE) POWDER [SKINFOOD CO., LTD.]

RED ORANGE SUN PACT SPF 50 PLUS PA PLUS PLUS PLUS (OCTINOXATE) POWDER [SKINFOOD CO., LTD.]
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NDC 76214-037-01
Set ID ae6af6e0-c7e9-4d5d-9b46-69989d4d8666
Category HUMAN OTC DRUG LABEL
Packager SKINFOOD CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 3.104%, ZINC OXIDE 2.88%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Talc, Mica (CI 77019), Methyl Methacrylate Crosspolymer, Silica, Nylon-12, Ethylene/Acrylic Acid Copolymer, Methylene Bis-Benzotriazolyl Tetramethylbutylpheno, Trimethylolpropane Triethylhexanoate, Phenyl Trimethicone, Magnesium Myristate, Dimethicone, Aluminum Hydroxide, Methylparaben, MethiconeDimethicone/Methicone Copolymer, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Fragrance(Parfum), Propylparaben, Iron Oxides (CI 77499), Citrus Aurantium Dulcis (Orange) Fruit Extract, Caprylic/Capric Triglyceride, Solanum Lycopersicum (Tomato) Fruit Oil, Water

  • PURPOSE

    Purpose: Protects skin from UV rays.

  • WARNINGS

    Warnings:
    For external use only.
    Avoid contact with eyes.
    Discontinue use if signs of irritation appear.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indication and usage:
    Using the enclosed puff, apply evenly onto the entire face.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Give a smooth tapping massage around your skin with the enclosed puff, and reapply to areas which produce sebum secretion as often as possible to give a fresh finish.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    RED ORANGE SUN PACT  SPF 50 PLUS PA PLUS PLUS PLUS
    octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-037
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.66 g  in 9.5 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE0.29 g  in 9.5 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE0.27 g  in 9.5 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ORANGE (UNII: 5EVU04N5QU)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TOMATO (UNII: Z4KHF2C175)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-037-019.5 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2011
    Labeler - SKINFOOD CO., LTD. (690324173)
    Registrant - SKINFOOD CO., LTD. (690324173)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINFOOD CO., LTD.690324173manufacture

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