AUSTRALIAN GOLD BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone 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 3 %, Homosalate 7.5 %, Octisalate 5 %,  Octocrylene 2.75 %, Oxybenzone 2 %

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 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, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Cholecalciferol, Coffea Arabica Fruit Extract, Disodium EDTA, Glycerin, Hydroxyprophyl Methylcellulose, Isopropylphtalimide, Lactobacillus/Arundinaria Gigantea Leaf Ferment Filtrate (Bamboo Isoflavones), Methylisothiazolinone, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Buter, Tocopheryl Acetate, Triethanolamine, 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

CARIBBEAN

GOLD

SUNSCREEN LOTION

BROAD

SPECTRUM

SPF 30

Infused wih antioxidant

Bamboo Isoflavones

PROTECT-HYDRATE-FIRM

• island extracts
• deeply nourishes
• vitamin enriched

PARABEN, FRAGRANCE

AND PABA-FREE

Water resistant

(80 Minutes)

8 FL OZ (237 mL)

CARIBBEAN

GOLD

SUNSCREEN LOTION

BROAD

SPECTRUM

SPF 30

Infused wih antioxidant

Bamboo Isoflavones

PROTECT-HYDRATE-FIRM

• island extracts
• deeply nourishes
• vitamin enriched

PARABEN, FRAGRANCE

AND PABA-FREE

Water resistant

(80 Minutes)

0.34 FL OZ (10 mL)

INGREDIENTS AND APPEARANCE

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	76.1 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50.8 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
3-BUTYLPHTHALIDE (UNII: 822Q956KGM)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q)
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0040-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2013
2	NDC: 58443-0040-2	10 mL in 1 PACKET; Type 0: Not a Combination Product	12/15/2013

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

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0040) , pack(58443-0040) , manufacture(58443-0040) , analysis(58443-0040)