Label: AUSTRALIAN GOLD SPF 30 WITH INSECT REPELLENT- octinoxate, octisalate, octocrylene, oxybenzone spray

  • 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 September 23, 2020

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  • Active Ingredients

    Octinoxate 7.5%

    Octisalate 5%

    Octocrylene 5%

    oxybenzone 4%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep away from face to avoid breathing it. Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swalowed, get medical help or contact a Poison Control Center right away.

    Flammable: Avoid fire, flame heat and smoking. Contents under pressure. Do not puncture or incinerate. Store at temperatures below 130°F.

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early sking aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging

  • Directions

    • shake well before use
    • apply liberally 15 minutes before sun exposure and rub into skin
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months: Ask a doctor

  • Inactive ingredients

    Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Extract, Ethyl Butylacetylaminopropionate, Fragrance, Glycine Soja (Soybean) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, SD Alcohol 40-B, Tocopheryl Acetate

  • Other information

    • Protect the product in this container from excessive heat and direct sun
    • May stain some fabrics or surfaces
  • Questions or comments?

    Call toll free 1-885-548-4653

  • AUSTRALIAN GOLD SPF 30 CONTINUOUS SPRAY SUNSCREEN with Insect Repellent

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  SPF 30 WITH INSECT REPELLENT
    octinoxate, octisalate, octocrylene, oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALCOHOL (UNII: 3K9958V90M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ETHYL BUTYLACETYLAMINOPROPIONATE (UNII: 65GQA237EH)  
    OCTOXYNOL-7 (UNII: 8419DEW37J)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    Product Characteristics
    Coloryellow (Colorless to very light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0162-4159 g in 1 CAN; Type 0: Not a Combination Product09/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/03/2019
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0162) , analysis(13630-0162)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0162) , pack(13630-0162)
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