Active ingredients

Avobenzone 1 %

Octocrylene 1 %

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging

For external use only

Do not use on damaged or broken skin.

When using this product keep away from face to avoid breathing it. 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

shake well before use
apply liberally 15 minutes before sun exposure and rub into skin
hold container 4 to 6 inches from the skin to apply
do not spray directly into face. Spray on hands then apply to face
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months: Ask a doctor

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil, Acetylated Lanolin Alcohol, Fragrance, Isopropyl Lanolate, VP/Hexadecene Copolymer, Cetyl Acetate, Aleurites Moluccana Seed Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, BHT, Tocopheryl Acetate, Diethylhexyl Syringylidene-Malonate, Aloe Barbadensis Leaf Extract, Caprylic/Capric Triglyceride, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Daucus Carota Sativa (Carrot) Seed Oil

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 BROAD SPECTRUM SPF 4
avobenzone, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0610
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	9 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
KUKUI NUT OIL (UNII: TP11QR7B8R)
OLIVE OIL (UNII: 6UYK2W1W1E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ACETATE (UNII: 4Q43814HXS)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
CARROT SEED OIL (UNII: 595AO13F11)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOPROPYL LINOLEATE (UNII: 4MW1E9AT4H)
TEA TREE OIL (UNII: VIF565UC2G)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRICAPRIN (UNII: O1PB8EU98M)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0610-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	12/22/2020

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0610) , pack(58443-0610) , manufacture(58443-0610) , analysis(58443-0610)

Australian Gold Spray Oil Sunscreen Broad Spectrum SPF 4