Label: AUSTALIAN GOLD SPF 6 SUNSCREEN LOW PROTECTION- n/a spray

  • NDC Code(s): 58443-0318-4
  • 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 September 28, 2022

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  • Active Ingredients

    Avobenzone 1%

    Octocrylene 0.85%

    Oxybenzone 0.5%

  • 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.

  • 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

    Acetylated Lanolin Alcohol, Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Acetate, Daucus Carota Sativa (Carrot) Seed Oil, Diethylhexyl Syringylidenemalonate, Fragrance, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Lanolate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Terminalia Ferdinandiana (Kakadu Plum) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, VP/Hexadecene Copolymer

  • Other Information

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

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

  • Australian Gold Spray Oil Sunscreen Hydrating formula SPF 6 LOW PROTECTION

    Principle Display LabelPrinciple Display Label

  • INGREDIENTS AND APPEARANCE
    AUSTALIAN GOLD  SPF 6 SUNSCREEN LOW PROTECTION
    n/a spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.65 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LANOLIN ACID (UNII: D1CZ545P7Z)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    COUMARIN (UNII: A4VZ22K1WT)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0318-4237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/30/2017
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0318) , manufacture(58443-0318) , label(58443-0318) , analysis(58443-0318)
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