Active Ingredients

Avobenzone 1%

Octisalate 3%

Octocrylene 2%

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

Water/Aqua/Eau, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, Caramel, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trimethylsiloxysilicate, Sodium Hydroxide, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Propylene Glycol, Polysorbate 20, Sorbitan Oleate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Fragrance (Parfum), Phenoxyethanol, Ethylhexylglycerin

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 INSTANT BRONZER 8 SPRAY GEL SUNSCREEN

Principal Display Label

AUSTRALIAN GOLD INSTANT BRONZER SPF 8 SUNSCREEN
avobenzone, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0279
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	9.35 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	18.7 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	28.05 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYPROMELLOSES (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARAMEL (UNII: T9D99G2B1R)
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TEA TREE OIL (UNII: VIF565UC2G)
OLIVE OIL (UNII: 6UYK2W1W1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Product Characteristics
Color	brown (Caramel)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0279-4	237 mL in 1 BOTTLE; 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(58443-0279) , manufacture(58443-0279) , label(58443-0279) , analysis(58443-0279)

Australian Gold Instant Bronzer 8 Spray Gel Sunscreen