Active Ingredients

Avobenzone 3%

Homosalate 15%

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 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, & sunglasses.
Children under 6 months: Ask a doctor

Inactive Ingredients

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

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 Plant Based Lotion Sunscreen SPF 70

Principal Display Label

AUSTRALIAN GOLD SPF 70
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0374
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.4 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	147 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)

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:58443-0374-4	177 mL in 1 TUBE; Type 0: Not a Combination Product	12/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/11/2020

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	pack(58443-0374) , manufacture(58443-0374) , label(58443-0374) , analysis(58443-0374)

Australian Gold SPF 70 Plant Based Lotion Sunscreen