AUSTRALIAN GOLD BROAD SPECTRUM SPF 15- avobenzone, octocrylene and octisalate 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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PRINCIPAL DISPLAY PANEL - 177 mL Can Label

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

Exotic Blend

# 1 Fragrance

15

Continuous Spray Sunscreen

with instant Bronzer

BROAD SPECTRUM SPF 15

WATER RESISTANT(80 MINUTES)

Australian Gold

177 mL / 6 Fl. Oz

Active ingredients

Avobenzone 2 %, Octisalate 5 %, Octocrylene 2.75 %

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on broken or damaged 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 1200F

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If 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 on face. Spray on hands and apply to face
  • do not apply in windy conditions
  • use in well-ventilated areas
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

Inactive Ingredients

Blue 1 (CI 42090), Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Polyester-8, Red 40 (CI 16035), SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Yellow 5 (CI 19140), Water (aqua)

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)

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 15
avobenzone, octisalate and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:13630-0011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE163 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE224.1 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE407.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIETHYLHEXYL 2,6-NAPHTHALATE 
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) 
ALCOHOL 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
WATER 
FD&C YELLOW NO. 5 
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0011-4177 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/03/2012
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0011), pack(13630-0011)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0011)

Revised: 11/2013
 
Prime Packaging, Inc.