Label: AUSTRALIAN GOLD SPF 30 SPORT ULTRA CHILL- octisalate, avobenzone, homosalate, octocrylene lotion

  • NDC Code(s): 58443-0602-3
  • Packager: Prime Enterprises Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2024

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  • Purpose

    Sunscreen

  • Active Ingredients

    Avobenzone 3%

    Homosalate 7.5%

    Octisalate 5%

    Octocrylene 5%

  • 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 useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctorif rash occurs

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures.Spending time in 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 value of 15 or higher and other sun protection measures including:
    • limit time in 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, Aluminum Starch Octenylsuccinate, Polyethylene, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Sodium Hydroxide, Carbomer, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Ethylhexylglycerin, Allantoin, Menthol, Camellia Oleifera (Green Tea) Leaf Extract, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Cetyl Phosphate, Melaleuca Alternifolia (Tea Tree) Leaf 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)

  • Australian Gold SPF 30 Lotion Sport Ultra Chill

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  SPF 30 SPORT ULTRA CHILL
    octisalate, avobenzone, homosalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE74.48 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE49.65 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.79 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.65 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0602-330 mL in 1 PACKET; Type 0: Not a Combination Product10/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/14/2019
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0602) , manufacture(58443-0602) , label(58443-0602) , analysis(58443-0602)
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