AUSTALIAN GOLD SPF 6 SUNSCREEN LOW PROTECTION- n/a spray

Austalian Gold by

Drug Labeling and Warnings

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

Drug Details [pdf]

INACTIVE INGREDIENTS

Helianthus Annuus (Sunflower) Seed Oil, Acetylated Lanolin Alcohol, Butyl Methoxydibenzoylmethane, Olea Europaea (Olive) Fruit Oil, Octocrylene, Fragrance (Parfum), Limonene, Benzophenone-3, Isopropyl Lanolate, VP/Hexadecene Copolymer, Cetyl Acetate, Tocopheryl Acetate, BHT, Daucus Carota Sativa (Carrot) Seed Oil, Diethylhexyl Syringylidenemalonate, Glycine Soja (Soybean) Oil, Coumarin, Linalool, Caprylic/Capric Triglyceride, Theobroma Cacao (Cocoa) Seed Butter, Citral, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Seed Oil, Aloe Barbadensis Leaf Extract

Directions

• 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 on to face
• spray on hands then apply to face
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures Spending time ine 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 valvue of 15 or higher and other sun protecion measures including:
• limit tim ein the sun, especially from 10am-2pm
• wear long sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Other Information

• Carrot Oil: Extracted from the seed of the carrot plant, this essential oil aids in moisturization for improved skin hydration
• Australian Naturals: Kakadu Plum and tea tree oil, both powerful antioxidants, help protect skin from free radicals
• Aloe Vera: Provides natural soothign and conditioning to skin
• Fragrane: take an instant vacation with the signature cocoa dreams fragrance

Australian Gold Spray Oil Sunscreen Hydrating formula SPF 6 LOW PROTECTION

INGREDIENTS AND APPEARANCE

AUSTALIAN GOLD  SPF 6 SUNSCREEN LOW PROTECTION
n/a spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0318
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARROT SEED OIL (UNII: 595AO13F11)
COCOA BUTTER (UNII: 512OYT1CRR)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
COUMARIN (UNII: A4VZ22K1WT)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LANOLIN ACID (UNII: D1CZ545P7Z)
TEA TREE OIL (UNII: VIF565UC2G)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SOYBEAN OIL (UNII: 241ATL177A)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLIVE OIL (UNII: 6UYK2W1W1E)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ACETATE (UNII: 4Q43814HXS)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0318-4	237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/30/2017

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0318) , manufacture(58443-0318) , label(58443-0318) , analysis(58443-0318)