AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 WITH INVISIDRY TECHNOLOGY- avovenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, 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 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. Keep away from face to avoid breathing it. Content 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

Inactive Ingredients

Acacia Senegal Flower/Stem Extract, Blue 1 (Cl 42090), Camellia Sinensis (Green Tea) Leaf Extract, Coddea Arabica (Kona Coffee) Seed Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glycerin, Polyester-8, Propylene Glycol, Red-40 (Cl 16035), SD Alcohol 40-B (Alcohol Denat), Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, TocopherylAcetate, VA/Butyl Maleate/Isobomyl Acrylate Copolymer, Water (Aqua), Yellow 5 (Cl 19140)

Other information

Questions or Comments?

Call toll free 1-800-LIV-GOLD (548-4653)

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

Exotic Blend

#1 Fragrance

Sheer Coverage

30

Continuous Spray

Sunscreen

Invisidry™ Technology

Kona Coffee

Infused Bronzers

Broad Spectrum SPF 30

Water Resistant

(80 Minutes)

Autralian

G old®

177 mL / 6Fl. Oz

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 30 WITH INVISIDRY TECHNOLOGY
avovenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0086
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) HOMOSALATE64.5 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) OXYBENZONE17.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ACACIA SENEGAL FLOWER (UNII: 72P931MTC2)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0086-4177 mL in 1 CAN; Type 0: Not a Combination Product10/22/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/22/2012
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0086) , analysis(13630-0086)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0086) , pack(13630-0086)

Revised: 1/2020
Document Id: 9c5c3921-6c5a-7b53-e053-2995a90aa31e
Set id: 7de466cf-0718-410f-aab1-b7e539b34567
Version: 3
Effective Time: 20200117
 
Prime Packaging, Inc.