Label: AUSTRALIAN GOLD INSTANT BRONZER BROAD SPECTRUM SPF 4 SUNSCREEN- avobenzone, octocrylene spray

  • NDC Code(s): 58443-0633-4
  • 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 August 4, 2023

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  • INACTIVE INGREDIENTS

    Water, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, Butylphthalimide, Caramel, Phenoxyethanol, Fragrance, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Isopropylphthalimide, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Trimethoxysiloxysilicate, 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

  • Warnings

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

    For external use only

    Do not useon 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 doctorif rash occurs

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

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Active Ingredients

    Avobenzone 1%

    Octocrylene 1%

  • Directions

    • shake well before use
    • apply liberally 15 minutes before sun exposure and rub into skin
    • hold container 4 to 6 inches from 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
  • 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 INSTANT BRONZER SPF 4 BROAD SPECTRUM Sunscreen

    Principal Display FrontPrincipal Display Back

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  INSTANT BRONZER BROAD SPECTRUM SPF 4 SUNSCREEN
    avobenzone, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0633
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    CARAMEL (UNII: T9D99G2B1R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    Product Characteristics
    Colorbrown (Caramel) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0633-4237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/04/2023
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0633) , manufacture(58443-0633) , label(58443-0633) , analysis(58443-0633)
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