Australian Gold Instant Bronzer Spray Gel Sunscreen SPF 15

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]

AUSTRALIAN GOLD SPF 15- avobenzone, octisalate, octocrylene spray 
Prime Enterprises, Inc.

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Australian Gold Instant Bronzer Spray Gel Sunscreen SPF 15

Active Ingredients

Avobenzone 2%

Octisalate 5%

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 use

on damaged or broken skin

When using this product

keep away form face to avoid breathing it. 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

shake well before use

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 into 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 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

Other information

Protect this product form excessive heat and direct sun

May stain some fabrics or surfaces

Questions or comments?

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

Inactive Ingredients

Water/Aqua/Eay, Aloe Barbadensis Leaf Juice, Glycerin, Butylphthalimide, Caramel, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trimethylsiloxysilicate, Sodium Hydroxide, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Propylene Glycol, Polysorbate 20, Sorbitan Oleate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Isopropylphthalimide, Fragrance (parfum), Phenoxyethanol, Ethylhexylglycerin

Australian Gold Instant Bronzer Spray Gel Sunscreen SPF15

AUSTRALIAN GOLD  SPF 15
avobenzone, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0381
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	19.4 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	19.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TEA TREE OIL (UNII: VIF565UC2G)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
CARAMEL (UNII: T9D99G2B1R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
OLIVE OIL (UNII: 6UYK2W1W1E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: 58443-0381-3	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/08/2019	01/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/08/2019	01/31/2024

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(58443-0381) , label(58443-0381) , analysis(58443-0381) , pack(58443-0381)

Revised: 8/2024

Document Id: 1f931b07-4f92-839b-e063-6394a90a05cb

34390-5

Set id: b83f37ff-9e72-6a69-e053-2995a90a73ec

Version: 2

Effective Time: 20240813