AUSTRALIAN GOLD SPF 15 C/S SUNSCREEN WITH BRONZER- avobenzone, octisalate, and octocrylene spray 
Prime Packaging 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.

----------

Australian Gold SPF 15 C/S Sunscreen with Bronzer

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 1.85%

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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F

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

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

Other Information

Question or comments?

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

Australian Gold SPF 15 C/S Sunscreen with Bronzer

Principal Display Image

AUSTRALIAN GOLD  SPF 15 C/S SUNSCREEN WITH BRONZER
avobenzone, octisalate, and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE16.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
ALCOHOL (UNII: 3K9958V90M)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
WATER (UNII: 059QF0KO0R)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0101-4240 mL in 1 CAN; Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2016
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0101) , analysis(13630-0101)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0101) , label(13630-0101)

Revised: 1/2020
Document Id: 9c5c3921-6c7e-7b53-e053-2995a90aa31e
Set id: 28d816e7-3b9a-2014-e054-00144ff88e88
Version: 2
Effective Time: 20200117
 
Prime Packaging Inc.