Label: OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN- octinoxate,4-methylbenzylidene camphor and zinc cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 11, 2012

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  • Active ingrdient

    Octyl Methoxycinnamate - 9% (90 mg/ml)
    4-Methylbenzylidene Camphor - 1.3%  (13 mg/ml)
    Zinc Oxide - 8% (80 mg/ml)
  • Purpose

    Sunscreen and Insect Repellent.

  • Indication and Usage

    Helps prevent sunburn. if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Dosage and Administration

    Apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours.

  • Warnings

    For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if a rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact the Poison Control Center right away.

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF or 15 or higher and other sun protection measures including: limit time in the sun, especially between 10 a.m – 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. children under 6 months: Ask a doctor.



  • Inactive Ingredients

    Eucalyptus Leaf Oil (Eucalyptus Polybractea),  Leptospermum Petersonii Leaf Oil (Leptospermum Petersonii), Tea Tree Oil ( Melaleuca Alternifolia) Vanilla,Actilastin 1000,
  • Keep out of Reach of Children

    Keep Out of Reach of Children
  • Product Label


    obc 1 lab

    obc 2 lab




  • INGREDIENTS AND APPEARANCE
    OUTBACK 2-IN-1  INSECT REPELLENT AND PROTECTIVE SUNSCREEN
    octinoxate,4-methylbenzylidene camphor and zinc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43979-445
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE90 mg  in 1 mL
    ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE13 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)  
    LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorVANILLA (vanila) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43979-445-013 mL in 1 POUCH
    2NDC:43979-445-0350 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2012
    Labeler - Elmore Oil Company Pty Ltd (755881968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elmore Oil Company Pty Ltd755881968manufacture, pack, label
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