Label: AUSTALIAN GOLD BROAD SPECTRUM SPF 15 SUNSCREEN- octisalate, avobenzone, octocrylene lotion

  • NDC Code(s): 58443-0603-4
  • Packager: Prime Enterprises Inc.
  • Category: HUMAN OTC DRUG LABEL

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 January 9, 2023

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  • Active Ingredients

    Avobenzone 2.0%

    Octisalate 5.0%

    Octocrylene 2%

  • 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 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

    • 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
    • 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 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

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, Camellia Oleifera (Green Tea) Leaf Extract, Caramel, Carbomer, Ethylhexylglycerin, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyethylene, Polysorbate 20, Sodium Hydroxide, Sorbitan Oleate,Tetrasodium Glutamate Diacetate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, 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 Broad Spectrum SPF 15

    Principle Display LabelPrinciple Display Label

  • INGREDIENTS AND APPEARANCE
    AUSTALIAN GOLD  BROAD SPECTRUM SPF 15 SUNSCREEN
    octisalate, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    CARAMEL (UNII: T9D99G2B1R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Product Characteristics
    Colorbrown (Caramel) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0603-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02010/17/2019
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0603) , manufacture(58443-0603) , label(58443-0603) , analysis(58443-0603)
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