JUSTICE BY AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 PINK GLITTER SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Justice by Australian Gold by

Drug Labeling and Warnings

Justice by Australian Gold by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 4%

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
• 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice Powder, Aluminum, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyethylene, Polyethylene Terephthalate, Polysilicone-15, Polysorbate 20, Polyurethane-33, Propylene Glycol, Red 34, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, Yellow 5

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)

Justice by Australian Gold PINK GLITTER SUNSCREEN LOTION SPF 50 Flamingo Fuit Punch

INGREDIENTS AND APPEARANCE

JUSTICE BY AUSTRALIAN GOLD  BROAD SPECTRUM SPF 50 PINK GLITTER SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)
D&C RED NO. 34 (UNII: BAN556989E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
COCOA BUTTER (UNII: 512OYT1CRR)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 1.00-2.00) (UNII: KJ6GWA9DJ0)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OLIVE OIL (UNII: 6UYK2W1W1E)
TEA TREE OIL (UNII: VIF565UC2G)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALLANTOIN (UNII: 344S277G0Z)
POLYSILICONE-15 (UNII: F8DRP5BB29)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM (UNII: CPD4NFA903)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER 980 (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Product Characteristics
Color	white (Off-white with Pink shimmer)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0253-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/07/2017

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0253) , manufacture(58443-0253) , label(58443-0253) , analysis(58443-0253)