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

  • 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 0.5%, Octocrylene 1%, Oxybenzone 0.5%

  • PURPOSE

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer /Skin Aging 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. Contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F

    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.

    Flammable: Do not use near heat, flame or while smoking

  • 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 on face. Spray into hands and apply to face
    • do not apply in windy conditions
    • use in well-ventilated areas
    • 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

    Blue 1 (CI 42090), C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Polyester-8, Red 40 (CI 16035), SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Yellow 5 (CI 19140), Water (Aqua)

  • Other information

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

    Questions or Comments?

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

  • PRINCIPAL DISPLAY PANEL - 177 mL Can Label

    PRINCIPAL DISPLAY PANEL - 177 mL Can Label

    Exotic Blend

    #1 Fragrance

    4

    Continuous Spray Sunscreen

    with instant BRONZER

    BROAD SPECTRUM SPF 4

    WATER RESISTANT(80 MINUTES)

    Australian Gold

    177 mL / 6 Fl. Oz

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  BROAD SPECTRUM SPF 4
    avobenzone, octocrylene, and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4.03 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8.06 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.03 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0008-4177 mL in 1 CAN; Type 0: Not a Combination Product03/21/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/21/2012
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0008) , pack(13630-0008)
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