Label: AUSTRALIAN GOLD SPF 50- avobenzone, homosalate, octisalate, octocrylene 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 February 23, 2023

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 5%

  • 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 away from face to avoid breathing it . 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.

    Flammable: Avoid fire, flame, heat, and smoking. Contents under pressure. Do not puncture or incinerate. Do no store at temperatures above 120°F (50°C).

  • Directions

    • shake well before use
    • applyliberally 15 minutes before sun exposure and rub into skin
    • hold container 4 to 6 inches from the skin to apply
    • apply liberally 15 minutues before sun exposure
    • do not spray directly into face. Spray on hands then apply to face
    • do not apply in windy conditions
    • use in a well-ventilated area
    • 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 of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a. m. - 2 p. m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Polyester-8, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil

  • Other Information

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics or surfaces
  • Question or comments?

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

  • Australian Gold SPF 50 Continuous Sunscreen Spray

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    AUSTRALIAN GOLD  SPF 50
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0269
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.08 g  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE83.6 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.8 g  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE41.8 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Coloryellow (Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0269-4203 mL in 1 CAN; Type 0: Not a Combination Product11/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02011/18/2019
    Labeler - Prime Packaging Inc. (805987059)
    Registrant - Prime Packaging Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc101946028manufacture(13630-0269) , analysis(13630-0269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging Inc.805987059pack(13630-0269) , label(13630-0269)
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