Label: AUSTALIAN GOLD SENSITIVE SUN PROTECTION SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 58443-0618-4
  • 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 March 20, 2023

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octocrylene 5%

    Octisalate 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 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

    Water, Aloe Barbadensis Leaf Juice, Glycerin,Polyethylene,C12-15 Alkyl Benzoate,Phenoxyethanol, Polysorbate 20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Sodium Hydroxide,Helianthus Annuus (Sunflower) Seed Oil,Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Propylene Glycol, Camellia Sinensis (Green Tea) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride

  • 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 Little Joey Sensitive Sun Protection SPF 50

    Principle Display LabelPrinciple Display Label

  • INGREDIENTS AND APPEARANCE
    AUSTALIAN GOLD  SENSITIVE SUN PROTECTION SPF 50
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0618
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.58 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE98.6 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.3 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE49.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    Colorwhite (White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0618-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02002/04/2020
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0618) , manufacture(58443-0618) , label(58443-0618) , analysis(58443-0618)
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