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 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 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

Aloe Barbadensis Leaf Juice, Water, Cocos Nucifera (Coconut) Oil, Glycerin, Tapioca Starch, VP/Acrylates/Lauryl Methacrylate Copolymer, Phenoxyethanol, Acrylic Acid/VP Crosspolymer, Fragrance, Sodium Hydroxide, Caprylyl Glycol, Polyacrylate-13, Ethylhexylglycerin, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Polyisobutene, Polymethylsilsesquioxane, Polysorbate 20

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

Principle Display Label

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0505
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.86 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	96.2 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48.1 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	48.1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COCONUT OIL (UNII: Q9L0O73W7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAURYL METHACRYLATE (UNII: B6L83074BZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0505-3	29 mL in 1 TUBE; Type 0: Not a Combination Product	06/08/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/08/2021

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0505) , pack(58443-0505) , manufacture(58443-0505) , analysis(58443-0505)