AUSTRALIAN GOLD X-TREME SPORT SPF 30 C/S SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Australian Gold by

Drug Labeling and Warnings

Australian Gold by is a Otc medication manufactured, distributed, or labeled by Prime Packaging Inc., Prime Enterprises Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 2%

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 away from face to avoid breathing it

• keep out of eyes. Rinse with water to remove.

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.

Caution: Flammable: Avoid fire, flame, heat and smoking. Contents under pressure. Do not puncture or incinerate. Store at temperature below 120ºF (48ºC). Intentional misuse by deliberately concentrating and inhaling can be harmful or fatal.

Directions

• Shake well before use
• Apply liberally 15 minutes before sun exposure and rub into skin
• 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 a well-ventilated 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 a 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 INGREDIENT

Acacia Senegal Flower/Stem Extract, Camellia Sinensis (Green Tea) Leaf Extract, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glycerin, Polyester-8, Propylene Glycol, SD Alcohol 40-B (Alcohol Denat.), Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water (Aqua)

Other Information

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

Question or comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Australian Gold X-treme Sport SPF 30 C/S Sunscreen

INGREDIENTS AND APPEARANCE

AUSTRALIAN GOLD  X-TREME SPORT SPF 30 C/S SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.2 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	63 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.1 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	16.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
ACACIA SENEGAL FLOWER (UNII: 72P931MTC2)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0105-4	177 mL in 1 CAN; Type 0: Not a Combination Product	04/07/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/07/2016

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(13630-0105) , analysis(13630-0105)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0105) , label(13630-0105)