AUSTALIAN GOLD BROAD SPECTRUM SPF 15 SUNSCREEN- octisalate, avobenzone, octocrylene lotion

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]

Active Ingredients

Avobenzone 2.0%

Octisalate 5.0%

Octocrylene 2%

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 useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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 and rub into skin
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection MeasuresSpending 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 time in the sun, especially from 10am-2pm
• wear long sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, Camellia Oleifera (Green Tea) Leaf Extract, Caramel, Carbomer, Ethylhexylglycerin, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyethylene, Polysorbate 20, Sodium Hydroxide, Sorbitan Oleate,Tetrasodium Glutamate Diacetate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, Sodium Chloride

Other Information

• Protect this product from excesive heat and direct sun
• May stain some frabics or surfaces

Questions or Comments?

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

Australian Gold INSTANT BRONZER Broad Spectrum SPF 15

INGREDIENTS AND APPEARANCE

AUSTALIAN GOLD  BROAD SPECTRUM SPF 15 SUNSCREEN
octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
OLIVE OIL (UNII: 6UYK2W1W1E)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
CARAMEL (UNII: T9D99G2B1R)
TEA TREE OIL (UNII: VIF565UC2G)
COCOA BUTTER (UNII: 512OYT1CRR)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)

Product Characteristics
Color	brown (Caramel)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0603-3	30 mL in 1 PACKET; Type 0: Not a Combination Product	10/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/17/2019

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0603) , manufacture(58443-0603) , label(58443-0603) , analysis(58443-0603)