Label: THERADERMSPF 43 SPF 43- zinc oxide, octinoxate, octisalate emulsion


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Drug Label Information

Updated January 20, 2012

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  • Active Ingredients

    Zinc Oxide 7.50% ...................Sunscreen
    Octinoxate 7.50% ...................Sunscreen
    Octisalate 2.50% ...................Sunscreen

  • Uses

    Helps prevent sunburn and photo damage caused by UVA/UVB exposure.

  • Warnings

    • For External use only.
    • When using, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • Stop use and contact a doctor if irritation or rash develops.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
  • Directions

    • Apply generously 15 minutes before sun exposure.
    • Reapply to dry skin as needed.
    • May be applied before make-up

    Best used within 12 months of opening.

  • Inactive Ingredients

    Purified water, Isopropyl palmitate, Octyl stearate, Ethyl hexyl isononanoate,Cyclopentasiloxane, Cetearyl glucoside, Dimethicone, Glycereth-26, Sodium Hyaluronate, Panthenol, Allantoin, Oleth-3 phosphate, Hydroxyethyl Acrylate/Sodium acryloyl dimethyl taurate copolymer, Polyisobutene, PEG-7 trimethylolpropane coconut ether, Polyether-1, Phenoxyethanol, Butylene glycol, Iodopropynyl butylcarbamate, Tocopheryl acetate, Triethoxycaprylylsilane.

  • Label for Tube and Box

    Theraderm Tube LabelLabel

    Theraderm Box LabelBox

    zinc oxide, octinoxate, octisalate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66428-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.5 mL  in 100 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mL  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Octyl Stearate (UNII: 772Y4UFC8B)  
    Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Glycereth-26 (UNII: NNE56F2N14)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Panthenol (UNII: WV9CM0O67Z)  
    Allantoin (UNII: 344S277G0Z)  
    Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)  
    2-Hydroxyethyl Acrylate (UNII: 25GT92NY0C)  
    Polyisobutylene (1300 MW) (UNII: 241BN7J12Y)  
    Coconut Alcohol (UNII: 13F4MW8Y9K)  
    Polyester-7 (UNII: 0841698D2F)  
    Ethylene Oxide (UNII: JJH7GNN18P)  
    Polyethylene Glycol 350 (UNII: ZBR3T82M2V)  
    Polyisobutylene (1300 MW) (UNII: 241BN7J12Y)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66428-002-021 in 1 BOX
    190 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/20/2012
    Labeler - Therapon Skin Health, LP (792518995)
    NameAddressID/FEIBusiness Operations
    Swiss American Products, Inc.611921669manufacture