Australian Gold Extreme Sport SPF 30 Spray Gel

Australian Gold by

Drug Labeling and Warnings

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

Drug Details [pdf]

AUSTRALIAN GOLD SPF 30- avobenzone, homosalate, octisalate, octocrylene spray 
Prime Enterprises

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Australian Gold Extreme Sport SPF 30 Spray Gel

Acitve Ingredient

Avobenzone 3%, Homosalate 7.5 %, Octisalate 5%, Octocrylene 5%

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 from 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 increaes your risk of skin cancer and early sking aging. To decrease this risk, regularly use a suncreen 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

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Menthol, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate, Trimethylsiloxysilicate, Water

Other information

Protect this product from excessive heat and direct sun

May stain some fabrics or surfaces

Questions or comments?

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

Australian Gold Extreme Sport SPF 30 Spray Gel Sunscreen

AUSTRALIAN GOLD  SPF 30
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0371
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.4 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MENTHOL (UNII: L7T10EIP3A)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TEA TREE OIL (UNII: VIF565UC2G)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Product Characteristics
Color	white (White to Off White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0371-4	237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/06/2019	09/27/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/06/2019	09/27/2022

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0371) , label(58443-0371) , analysis(58443-0371) , pack(58443-0371)

Revised: 9/2022

Document Id: e9a9e37a-4740-0ffa-e053-2995a90ad921

34390-5

Set id: b2069b7f-9a48-5263-e053-2a95a90ab91a

Version: 2

Effective Time: 20220927