Label: RED ORANGE SUN SPF 45 PA PLUS PLUS PLUS- titanium dioxide 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: TITANIUM DIOXIDE 13.937%, ZINC OXIDE 2.94%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Talc, Mica (CI 77019), Silica, Aluminum Starch Octenylsuccinate, Dimethicone, Ethylhexyl Methoxycinnamate, Methicone, Iron Oxides (CI 77492), Triethoxycaprylylsilane, Citrus Aurantium Dulcis (Orange) Peel Oil, Iron Oxides (CI 77491), Aluminum Hydroxide, Methylparaben, Iron Oxides (CI 77499), Propylparaben

  • 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  SPF 45 PA PLUS PLUS PLUS
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-038
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2.79 g  in 20 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE0.59 g  in 20 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ORANGE (UNII: 5EVU04N5QU)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-038-0120 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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