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

  • 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 January 20, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • 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

  • INGREDIENTS AND APPEARANCE
    THERADERMSPF 43   SPF 43
    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)  
    Packaging
    #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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss American Products, Inc.611921669manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!