Label: TOMATO SUN SPF 36 PA PLUS PLUS- octinoxate cream

  • 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 7, 2011

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  • ACTIVE INGREDIENT

    Active ingredients: OCTINOXATE 6.5%, Titanium Dioxide 4.24%, Zinc Oxide 3.5%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Cyclomethicone, Dimethicone, Squalane, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-10 Dimethicone, Propylene Glycol, Triethanolamine, Dimethicone Copolyol, Hexyl Laurate, Cetyl Peg/Ppg-10/1 Dimethicone, Sorbitan Sesquioleate, Glycerin, Solanum Lycopersicum (Tomato) Extract, Silica, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Alumina, Methylparaben, Fragrance, Propylparaben, Imidazolidinyl Urea

  • 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:
    Use at the end of your daily skincare regimen.
    Apply liberally onto face and body before sun exposure avoiding the eye area.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    For best results, apply at least 15 to 20 minutes before sun exposure.
    Reapply frequently while out in the sun.

  • PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    TOMATO SUN  SPF 36 PA PLUS PLUS
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-035
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.25 mL  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2.12 mL  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.75 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    SQUALANE (UNII: GW89575KF9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOMATO (UNII: Z4KHF2C175)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    IMIDUREA (UNII: M629807ATL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-035-0150 mL in 1 BOTTLE
    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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