AUSTRALIAN GOLD BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene lotion

Australian Gold by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Avobenzone 2 %, Octisalate 5 %, and Octocrylene 2.75 %

PURPOSE

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.

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.

Directions

• apply liberally 15 minutes before sun exposure
• 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 Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT (Butylated Hydroxytoluene), Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Fragrance (Parfum), Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Phenyl Trimethicone, Polyethylene, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water (Aqua)

Other information

• protect this product from excesive heat and direct sun

QUESTIONS

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 177 mL  Tube Label

EXOTIC BLEND

#1 Fragrance

Sheer Coverage

15

Lotion Sunscreen

InvisiDry Technology

Clean and Hydrating

Broad Spectrum SPF 15

WATER RESISTANT

(80 MINUTES)

Australian

Gold

177 mL / 6 Fl. Oz

INGREDIENTS AND APPEARANCE

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 15
avobenzone, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	19.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48.7 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
STYRENE (UNII: 44LJ2U959V)
WATER (UNII: 059QF0KO0R)
GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
3-BUTYLPHTHALIDE (UNII: 822Q956KGM)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYSILICONE-15 (UNII: F8DRP5BB29)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0030-4	177 mL in 1 TUBE; Type 0: Not a Combination Product	10/25/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/25/2013

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0030) , pack(58443-0030) , manufacture(58443-0030) , analysis(58443-0030)