Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 5%

Purpose

Sunscreen

• 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.

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.

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-sleeved shirts, pants, hats, & sunglasses.
Children under 6 months: Ask a doctor

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

Principal Display Label

AUSTRALIAN GOLD INSTANT BRONZER 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotion

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	51.05 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.63 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51.05 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	76.575 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
TEA TREE OIL (UNII: VIF565UC2G)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARAMEL (UNII: T9D99G2B1R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CARBOMER 980 (UNII: 4Q93RCW27E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYPROMELLOSES (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
OLIVE OIL (UNII: 6UYK2W1W1E)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCOA BUTTER (UNII: 512OYT1CRR)
ALLANTOIN (UNII: 344S277G0Z)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0270-4	237 mL in 1 TUBE; Type 0: Not a Combination Product	10/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/31/2019

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc.		101946028	pack(58443-0270) , manufacture(58443-0270) , label(58443-0270) , analysis(58443-0270)