Label: RED ORANGE SUN PACT SPF 50 PLUS PA PLUS PLUS PLUS- octinoxate powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 9, 2011

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  • 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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