AUSTRALIAN GOLD BROAD SPECTRUM SPF 8- avobenzone, octocrylene and 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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PRINCIPAL DISPLAY PANEL - 177 mL Can Label

Exotic Blend

# 1 Fragrance

Continuous Spray Sunscreen

with instant BRONZER

BROAD SPECTRUM SPF 8

WATER RESISTANT(80 MINUTES)

Australian Gold

177 mL / 6 Fl. Oz

Active ingredients

Avobenzone 1 %, Octocrylene 2.75%, 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 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 into 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
children under 6 months: Ask a doctor

Inactive Ingredients

Blue 1 (CI 42090), C12-15 Alkyl Benzoate, 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 produtc 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 8
avobenzone, octocrylene, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:13630-0009
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (AVOBENZONE)	AVOBENZONE	81.8 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE)	OCTOCRYLENE	225 mg in 1 mL
OXYBENZONE (OXYBENZONE)	OXYBENZONE	81.8 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALKYL (C12-15) BENZOATE
FD&C BLUE NO. 1
DIETHYLHEXYL 2,6-NAPHTHALATE
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
FD&C RED NO. 40
ALCOHOL
FD&C YELLOW NO. 5
WATER

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0009-4	177 mL in 1 CAN

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/25/2012	04/25/2012

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0009), pack(13630-0009)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0009)

Revised: 1/2014

Document Id: 832629c3-ed1e-4eb7-a2f2-77a911176351

Set id: 2fed77b1-3cfd-41e1-a5b0-d1c47a909237

Version: 2

Effective Time: 20140113

Prime Packaging, Inc.