Active Ingredients

Avobenzone 3%

Homosalate 10%

Octocrylene 5%

Octisalate 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 and rub into skin
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
Sun Protection Measures Spending time ine 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 valvue of 15 or higher and other sun protecion measures including:
limit time in the sun, especially from 10am-2pm
wear long sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

Water, Aloe Barbadensis Leaf Juice, Glycerin,Polyethylene,C12-15 Alkyl Benzoate,Phenoxyethanol, Polysorbate 20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Sodium Hydroxide,Helianthus Annuus (Sunflower) Seed Oil,Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Propylene Glycol, Camellia Sinensis (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 Little Joey Sensitive Sun Protection SPF 50

Principle Display Label

AUSTALIAN GOLD SENSITIVE SUN PROTECTION SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0618
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.58 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	98.6 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.3 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COCOA BUTTER (UNII: 512OYT1CRR)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TEA TREE OIL (UNII: VIF565UC2G)
OLIVE OIL (UNII: 6UYK2W1W1E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0618-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	02/04/2020

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc.		101946028	pack(58443-0618) , manufacture(58443-0618) , label(58443-0618) , analysis(58443-0618)

Australian Gold Little Joey Sensitive Sun Protection SPF 50 (non-Kakadu)