Label: AUSTALIAN GOLD BROAD SPECTRUM SPF 30 SUNSCREEN- octisalate, avobenzone, octocrylene, homosalate spray

  • NDC Code(s): 58443-0612-4
  • 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 3, 2023

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  • Active Ingredients

    Avobenzone 3.0%

    Homosalate 7.5%

    Octisalate 5.0%

    Octocrylene 5.0%

  • Purpose

    Sunscreen

  • Uses

    • 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
  • 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 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
    • Sun Protection Measures Spending time ine the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF valvue of 15 or higher and other sun protecion measures including:
    • limit tim ein the sun, especially from 10am-2pm
    • wear long sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, Phenoxyethanol, Caramel, Phenoxyethanol, Fragrance, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Trimethylsiloxysilicate, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Sodium Hydroxide, Propylene Glycol, Sorbitan Oleate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride

  • Other Information

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

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

  • Australian Gold Instant Bronzer Spray Gel Sunscreen Broad Spectrum SPF 30

    Principle Display LabelPrinciple Display Label

  • INGREDIENTS AND APPEARANCE
    AUSTALIAN GOLD  BROAD SPECTRUM SPF 30 SUNSCREEN
    octisalate, avobenzone, octocrylene, homosalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0612
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE48 g  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.8 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48 g  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE75.15 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARAMEL (UNII: T9D99G2B1R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    Colorbrown (Caramel) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0612-4237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/30/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02010/30/2019
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028manufacture(58443-0612) , pack(58443-0612) , label(58443-0612) , analysis(58443-0612)
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