AUSTRALIAN GOLD CARROT OIL FORMULA BROAD SPECTRUM SPF 4- avobenzone, octocrylene, oxybenzone spray

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 1%, Octocrylene 0.85%, and Oxybenzone 0.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert:

Spending time in the sun inceases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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.

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

• spray liberally and spread evenly by hand 15 minutes before sun exposure
• do not spray directly into face. Spray on hands then apply to face.Use in a well-ventilated area
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months: Ask a doctor.

Inactive Ingrediets:

Acetylated Lanolin Alcohol, Aloe Barbadensis Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Acetate, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Seed Oil, Diethylhexyl Syringylidene-malonate, Fragrance (Parfum), Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Lanolate, Macadamia Integrifolia Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mineral Oil (Paraffinum Liquidum), Olea Europaea (Olive) Fruit Oil, Terminalia Ferdinandiana (Kakadu Plum) Seed Oil Extract, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, VP/Hexadecene Copolymer

Other information

• protect this product from excessive 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 - 237mL  Bottle Label

EXOTIC BLEND

#1 Fragrance

4

Spray Oil

Sunscreen

Carrot Oil Formula

Broad Spectrum SPF 4

WATER RESISTANT

(80 MINUTES)

AUSTRALIAN GOLD

237 mL / 8 Fl. Oz

INGREDIENTS AND APPEARANCE

AUSTRALIAN GOLD  CARROT OIL FORMULA BROAD SPECTRUM SPF 4
avobenzone, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0167
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	9 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.65 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ACETATE (UNII: 4Q43814HXS)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
CARROT SEED OIL (UNII: 595AO13F11)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LANOLIN (UNII: 7EV65EAW6H)
TEA TREE OIL (UNII: VIF565UC2G)
MINERAL OIL (UNII: T5L8T28FGP)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OLIVE OIL (UNII: 6UYK2W1W1E)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0167-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/05/2014

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0167) , pack(58443-0167) , manufacture(58443-0167) , analysis(58443-0167)