Active ingredients

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 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

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 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 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, C12-15 Alkyl Benzoate, Glycerin, Polyethylene, Phenoxyethanol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Sodium Hydroxide, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Ethylhexylglycerin, Allantoin, Aloe Barbadensis Leaf Juice, Camellia Oleifera (Green Tea) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract

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)

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

Principle Display Label

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0409
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.87 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	77.175 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51.45 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	51.45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
OLIVE OIL (UNII: 6UYK2W1W1E)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0409-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	07/13/2021

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0409) , pack(58443-0409) , manufacture(58443-0409) , analysis(58443-0409)