Australian Gold Extreme Sport SPF 30

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]

AUSTRALIAN GOLD EXTREME SPORT SPF 30- avobenzone, homosalate, octisalate, octocrylene 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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Australian Gold Extreme Sport SPF 30

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

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.

Flammable: Avoid fire, flame, heat, and smoking. Contents under pressure so not puncture or incinerate. Store at temperatures below 120°F (50°C).

Directions

• Shake well before use
• apply liberally 15 minutes before sun exposure and rub into skin to apply
• Hold container 4 to 6 inches from the skin to apply
• do not spray directly onto 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

Aloe Barbadensis Leaf Extract, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Menthol, Polyester-8, SD Alcohol 40-B, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Other information

• Protect this product from excessive heat and direct sun
• May stain some fabrics or surfaces

Questions or comments?

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

Australian Gold Extreme Sport SPF 30

AUSTRALIAN GOLD  EXTREME SPORT SPF 30
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0169
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
VINYL ACETATE (UNII: L9MK238N77)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TEA TREE OIL (UNII: VIF565UC2G)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	yellow (very light Yellow to yellow clear liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0169-4	170 g in 1 CAN; Type 0: Not a Combination Product	11/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/05/2019

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0169) , analysis(13630-0169)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0169) , pack(13630-0169)

Revised: 9/2020

Document Id: b078736f-836b-1b48-e053-2a95a90a7859

34390-5

Set id: b078729d-e108-ebd3-e053-2995a90ac644

Version: 1

Effective Time: 20200929