AUSTRALIAN GOLD BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene lotion 
Prime Enterprises, Inc.

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.

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Active ingredients

Avobenzone 2 %, Octisalate 5 %, and Octocrylene 2.75 %

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
  • 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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT (Butylated Hydroxytoluene), Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Fragrance (Parfum), Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Phenyl Trimethicone, Polyethylene, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water (Aqua)

Other information

  • protect this product from excesive heat and direct sun

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 177 mL  Tube Label

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label


EXOTIC BLEND

#1 Fragrance

Sheer Coverage

15

Lotion Sunscreen

InvisiDry Technology

Clean and Hydrating

Broad Spectrum SPF 15

WATER RESISTANT

(80 MINUTES)

Australian

Gold

177 mL / 6 Fl. Oz

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 15
avobenzone, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE48.7 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE26.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STYRENE (UNII: 44LJ2U959V)  
WATER (UNII: 059QF0KO0R)  
GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0030-4177 mL in 1 TUBE; Type 0: Not a Combination Product10/25/201302/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/25/201302/13/2019
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0030) , pack(58443-0030) , manufacture(58443-0030) , analysis(58443-0030)

Revised: 5/2022
 
Prime Enterprises, Inc.