Label: AUSTRALIAN GOLD BROAD SPECTRUM SPF 4- avobenzone, octocrylene oil

  • NDC Code(s): 58443-0610-4
  • Packager: Prime Enterprises, Inc.
  • 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 March 1, 2023

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  • Active ingredients

    Avobenzone 1 %

    Octocrylene 1 %

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

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

    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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well before use
    • apply liberally 15 minutes before sun exposure and rub into skin
    • hold container 4 to 6 inches from the skin to apply
    • do not spray directly into face. Spray on hands then apply to face
    • 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

    Helianthus Annuus (Sunflower) Seed Oil, Acetylated Lanolin Alcohol, Fragrance, Isopropyl Lanolate, VP/Hexadecene Copolymer, Cetyl Acetate, Aleurites Moluccana Seed Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, BHT, Tocopheryl Acetate, Diethylhexyl Syringylidene-Malonate, Aloe Barbadensis Leaf Extract, Caprylic/Capric Triglyceride, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Daucus Carota Sativa (Carrot) Seed Oil

  • Other information

    • Protect this product from excesive heat and direct sun
    • May stain some fabrics or surfaces
  • Questions or Comments?

    Call toll free 1-855-LIV-GOLD (548-4653)

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    Principle Display LabelPrinciple Display Label

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  BROAD SPECTRUM SPF 4
    avobenzone, octocrylene oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE9 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISOPROPYL LINOLEATE (UNII: 4MW1E9AT4H)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0610-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02012/22/2020
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0610) , pack(58443-0610) , manufacture(58443-0610) , analysis(58443-0610)
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