Australian Gold SPF 30 Sport Ultra Chill Spray Gel

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 30 SPORT ULTRA CHILL- octisalate, avobenzone, homosalate, octocrylene spray 
Prime Enterprises Inc.

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 SPF 30 Sport Ultra Chill Spray Gel

Purpose

Sunscreen

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

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

• 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 holds 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 value of 15 or higher and other sun protection 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, 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 Chloride, Sodium Hydroxide, Sorbitan Oleate, Tetrasodium Glutamate, Diacetate, Tocopheryl Acetate, Trimethylsiloxysilicate, Water

Other Information

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

Questions or Comments?

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

Australian Gold SPF 30 Lotion Sport Ultra Chill Spray Gel

AUSTRALIAN GOLD  SPF 30 SPORT ULTRA CHILL
octisalate, avobenzone, homosalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0634
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	72.75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	48.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.1 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
OLIVE OIL (UNII: 6UYK2W1W1E)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
TEA TREE OIL (UNII: VIF565UC2G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0634-4	237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	08/04/2023

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0634) , manufacture(58443-0634) , label(58443-0634) , analysis(58443-0634)

Revised: 8/2023

Document Id: 021b08c8-a0f6-fb35-e063-6394a90acf97

34390-5

Set id: 021b0c34-68c5-1735-e063-6294a90a3aaa

Version: 1

Effective Time: 20230804