AUSTRALIAN GOLD BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone 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.

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Active ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, Oxybenzone 4 %

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 incinirate. Do not store at temperatures above 120 0F

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

Acacia Senegal Flower/Stem Extract, Blue 1 (CI 42090), Camellia Sinensis (Green Tea) Leaf Extract, Coffea Arabica (Kona Coffee) Seed Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glycerin, Polyester-8, Propylene Glycol, Red 40 (CI 16035),  SD Alcohol 40-B (Alcohol Denat.), Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Aceate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, 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 Can Label

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

EXOTIC BLEND

#1 Fragrance

Sheer Coverage

50

Continuous Spray

Sunscreen

Invisidry Technology

Kona Coffee

Infused Bronzers

BROAD SPECTRUM SPF 50

WATER RESISANT

(80 MINUTES)

Australian Gold

177 mL / 6 Fl. Oz

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.8 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE86 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE43 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE23.7 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE34.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ACACIA SENEGAL FLOWER (UNII: 72P931MTC2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0027-4177 mL in 1 CAN; Type 0: Not a Combination Product06/14/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/14/2012
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0027) , analysis(13630-0027)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0027) , pack(13630-0027)

Revised: 1/2020
Document Id: 9c5c0604-bf61-b266-e053-2995a90a07bf
Set id: ed91c895-613f-4efc-80e2-a831d2934a54
Version: 3
Effective Time: 20200117
 
Prime Packaging, Inc.