AUSTRALIAN GOLD BROAD SPECTRUM SPF 8- avobenzone, 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 1 %, Octisalate 3 %, Octocrylene 0.85 %, Oxybenzone 1 %

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in well-ventilated area
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Children under 6 months: Ask a doctor

Inactive Ingredients

Blue 1 (CI 42090), C12-15 Alkyl Benzoate, Diehylhexyl 2,6-Napthalate, Fragrance (Parfum), Glycerin, Polyeser-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

  • protect this product from excesive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration

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

8

Continuous Spray Sunscreen

with instant

BONZER

Broad Spectrum SPF 8

WATER RESISTANT

(80 MINUTES)

Australian Gold

6 Fl. Oz (177 mL)

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 8
avobenzone, octisalate, octocrylene, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE8.4 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE25.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.2 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE8.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0020-4177 mL in 1 CAN; Type 0: Not a Combination Product10/23/201306/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02010/23/201306/30/2022
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0020) , analysis(13630-0020)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0020) , pack(13630-0020)

Revised: 6/2022
Document Id: e1e83a92-0ccd-374b-e053-2995a90abe92
Set id: 825cb7b9-126a-48ee-957b-3703eb73f342
Version: 4
Effective Time: 20220620
 
Prime Packaging, Inc.