Label: OUTBACK SERIES 2-IN-1 SUNSCREEN- octyl methoxycinnamate,avobenzone and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 11, 2013

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  • Active ingrdient

    Octyl Methoxycinnamate - 7.5%

     Avobenzone - 1.3%

     Zinc Oxide - 9.5%

  • Purpose

    Sunscreen 30+

  • 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

    Actilastin 1000, Melaleuca Alternifolia, Eucalyptus Polybractea, Citronella, Leptospermum Petersonii, Vanilla

  • Keep out of Reach of Children

    Keep Out of Reach of Children

  • Product Label


    obc 1 lab

    obc 2 lab




  • INGREDIENTS AND APPEARANCE
    OUTBACK SERIES 2-IN-1 SUNSCREEN 
    octyl methoxycinnamate,avobenzone and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43979-446
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE13 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)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43979-446-013 mL in 1 POUCH
    2NDC:43979-446-0375 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2013
    Labeler - Elmore Oil Company Pty Ltd (755881968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elmore Oil Company Pty Ltd755881968manufacture(43979-446) , pack(43979-446) , label(43979-446)
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