AUSTRALIAN GOLD BOAD SPECTRUM SPF 30- 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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Active ingredients

Avobenzone 3 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

Purpose

Sunscreen

Uses

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.

Flammable: Do not use near heat, flame or while smoking.

Directions

Inactive Ingredients

Blue 1 (CI 42090), Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glycerin, Polyester-8, Red 40 (CI 16035), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Water (Aqua), Yellow 5 (CI 19140)

Other information

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 177 mL  Bottle Label

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

EXOTIC BLEND

#1 Fragrance

30

Continuous Spray Sunscreen

with instant

BRONZER

BROAD SPECTRUM SPF 30

WATER RESISTANT (80 MINUTES)

Australian

Gold

6 FL OZ (177 mL)

AUSTRALIAN GOLD  BOAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0071
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.1 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE62.7 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.8 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE22.9 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE16.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0071-4177 mL in 1 BOTTLE; Type 0: Not a Combination Product11/06/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/06/2013
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0071) , pack(58443-0071) , manufacture(58443-0071) , analysis(58443-0071)

Revised: 1/2020
Document Id: 9c58e7f8-abdc-56a2-e053-2995a90a1f82
Set id: 9258acd6-a56d-4883-9f08-1213e181a80b
Version: 3
Effective Time: 20200117
 
Prime Enterprises, Inc.