Label: AUSTRALIAN GOLD BROAD SPECTRUM SPF 4- avobenzone, octocrylene and oxybenzone gel

  • 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 January 17, 2020

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  • Active ingredients

    Avobenzone 1 %, Octocrylene 0.85 %, and Oxybenzone 0.5 %

  • PURPOSE

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aing Alert:

    Spending time in the sun increases your risk of skin cancer 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 use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it.

    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

    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • hold container 4 to 6 inches from the skin to apply
    • do not spray directly into face. Spray on hands and apply to face. Use in a well-ventilated area
    • 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

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Dimethicone, Disodium EDTA, Fragrance (Parfum), Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Olea Europaea (Olive) Fruit Oil, Oleth 10, Phenoxyethanol, Polysilicone-15, Propylene Glycol, Sorbitan Oleate,Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water (Aqua)

  • Other information

    • protect this product from excesive heat and direct sun
    • avoid spraying on fabics - could cause discoloration
  • QUESTIONS

    Questions or Comments?

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

  • PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label


    EXOTIC BLEND

    #1 Fragrance

    4

    Spray Gel Sunscreen

    CLEAR

    BROAD SPECTRUM SPF 4

    WATER RESISTANT

    (80 MINUTES)

    Australian

    Gold

    237 mL / 8 Fl. Oz

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  BROAD SPECTRUM SPF 4
    avobenzone, octocrylene and oxybenzone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE9.8 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8.3 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    OLETH-10 (UNII: JD797EF70J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0076-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/21/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0076) , pack(58443-0076) , manufacture(58443-0076) , analysis(58443-0076)
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