AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 SHEER SUNSCREEN- avobenzone, homosalate, octisalate, 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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Australian Gold Broad Spectrum SPF 30 Sheer Sunscreen

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 2%

Purpose

Sunscreen

Uses

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Disodium EDTA, Fragrance (Parfum), Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Water (Aqua)

Other Information

Questions or Comments?

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

Australian Gold Broad Spectrum SPF 30 Sheer Sunscreen

Principal Display Image

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 30 SHEER SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20.4 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE76.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE28.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
LICORICE (UNII: 61ZBX54883)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0203-4177 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2014
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0203) , manufacture(58443-0203) , label(58443-0203) , analysis(58443-0203)

Revised: 1/2020
Document Id: 9c582eb0-d632-3048-e053-2995a90adbfd
Set id: 29c9cb6c-ef5c-3759-e054-00144ff88e88
Version: 2
Effective Time: 20200117
 
Prime Enterprises Inc.