Australian Gold Broad Spectrum SPF 50 Sunscreen Lotion

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 BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
Prime Enterprises, Inc.

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Australian Gold Broad Spectrum SPF 50 Sunscreen Lotion

Active ingredients

Avobenzone 3 %

Homosalate 10 %

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 useon damaged or broken skin

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

Stop use and ask a doctor ifrash 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
• 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 decease 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

Inactive Ingredients

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

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 Ultimate Hydrating SPF 50 Lotion Sunscreen

AUSTRALIAN GOLD  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0605
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.55 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	98.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.25 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COCOA BUTTER (UNII: 512OYT1CRR)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
TEA TREE OIL (UNII: VIF565UC2G)
ALLANTOIN (UNII: 344S277G0Z)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLIVE OIL (UNII: 6UYK2W1W1E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0605-3	30 mL in 1 PACKET; Type 0: Not a Combination Product	12/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/19/2020

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0605) , pack(58443-0605) , manufacture(58443-0605) , analysis(58443-0605)

Revised: 8/2024

Document Id: 209ad82d-b40a-28a0-e063-6294a90a864a

34390-5

Set id: 209aa32e-f9e8-f741-e063-6294a90a5981

Version: 1

Effective Time: 20240826