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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Carribean Gold by Australian Gold Continuous Spray Sunscreen Broad Spectrum SPF 50

Active ingredients

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

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 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 incinerate. 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 no use near heat, flame or while smoking.

Directions

spray liberral and spread evenly by hand 15 minutes before sun exposure
hold container 4 to 6 inches from the skin to apply
do no spray directly into face. Spray on hands then apply to face
do not apply in windy conditions
use in a well-venilated area
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

Aloe Barbadensis Leaf Juice, Cholecalciferol, Fragrance (Parfum), Lactobacillus/Arundinaria Gigantea Leaf Ferment Filtrate (Bamboo Isoflavones), SD Alcohol 40-B(Alcohol Denat.), Tocopheryl Acetate, VA/Butyl Maleate/Isobomyl Acrylate Copolymer, Glycerin, Coffea Arabica Fruit Extract

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

CARIBBEAN

GOLD

CONTINUOUS SPRAY

SUNSCREEN

BROAD

SPECTRUM

SPF 50

Infused with antioxidant

Bamboo Isoflavones

PROTECT-HYDRATE-FIRM

island extracts
deeply nourishes
vitamin enriched

HYPOALLERGENIC

PARABEN AND PABA-FREE

Water Resistant

(80 Minutes)

6 FL OZ (177 mL)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0063
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.5 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	84.9 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.5 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.4 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	34 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q)
CHOLECALCIFEROL (UNII: 1C6V77QF41)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0063-4	177 mL in 1 CAN; Type 0: Not a Combination Product	12/15/2013	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/15/2013	12/31/2018

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0063) , analysis(13630-0063)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0063) , pack(13630-0063)

Revised: 4/2022

Document Id: dbdaa971-a423-2d5d-e053-2995a90abee5

Set id: 1a098093-7ea4-44eb-968b-f240fcb1665b

Version: 4

Effective Time: 20220404

Prime Packaging, Inc.