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

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 Instant Bronzer Spray Gel Sunscreen Broad Spectrum SPF 4

Principle Display Label

AUSTRALIAN GOLD SPF 6 BRONZER OXYBENZONE
avobenzone, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0236
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	9.71 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.71 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
OLIVE OIL (UNII: 6UYK2W1W1E)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
TEA TREE OIL (UNII: VIF565UC2G)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
CARAMEL (UNII: T9D99G2B1R)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYPROMELLOSES (UNII: 3NXW29V3WO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

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:13630-0236-4	237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/18/2022

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0236) , analysis(13630-0236)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0236) , pack(13630-0236)