AUSTRALIAN GOLD BROAD SPECTRUM SPF 8- avobenzone, octocrylene, and oxybenzone 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 0.5 %, Octocrylene 2 %, and Oxybenzone 1.5 %

Purpose

Sunscreen

Uses

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.

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

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

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

8

Lotion Sunscreen

InvisiDry Technology

Clean and Hydrating

Broad Spectrum SPF 8

WATER RESISTANT

(80 MINUTES)

Australian

Gold

177 mL / 6 Fl. Oz

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 8
avobenzone, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4.9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE19.4 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE14.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STYRENE (UNII: 44LJ2U959V)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0029-4177 mL in 1 TUBE; Type 0: Not a Combination Product11/18/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/18/2013
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0029) , pack(58443-0029) , manufacture(58443-0029) , analysis(58443-0029)

Revised: 1/2020
Document Id: 9c58b46a-0c83-a377-e053-2a95a90ad113
Set id: acc957b7-e02c-4e22-80e0-ce6cb891f98e
Version: 3
Effective Time: 20200117
 
Prime Enterprises, Inc.