Just Shine by Australian Gold SPF 50 Glitter Sunscreen Spray

Australian Gold by

Drug Labeling and Warnings

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

Drug Details [pdf]

AUSTRALIAN GOLD JUST SHINE SPF 50 GLITTER SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray 
Prime Packaging Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Just Shine by Australian Gold SPF 50 Glitter Sunscreen Spray

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 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.

Flammable: Avoid fire, flame, heat and smoking. Contents under pressure. Do not puncture or incinerate. Store at temperatures below 120°F (50°C). Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

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
• do not apply in windy conditions
• use in a well-ventilated area
• reapply:
• after 80 minutes of swimming and 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 a 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

Aloe Barbadensis Leaf Juice, Butane, Carmine, Cholecalciferol, Fragrance, Mica, Propane, SD Alcohol 40-B, Titanium Dioxide, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

• Protect this product from excessive heat and direct sun
• May stain some fabrics or surfaces

Question or comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Just Shine SPF 50 Glitter Sunscreen Spray

AUSTRALIAN GOLD  JUST SHINE SPF 50 GLITTER SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	85 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.38 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	34 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTANE (UNII: 6LV4FOR43R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPANE (UNII: T75W9911L6)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
PIGMENT RED 5 (UNII: 91OZU993LX)

Product Characteristics
Color	pink (Pink Shimmer)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0212-4	182 mL in 1 CAN; Type 0: Not a Combination Product	12/30/2019	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	12/30/2019	12/31/2022

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(13630-0212) , analysis(13630-0212)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	label(13630-0212) , pack(13630-0212)

Revised: 6/2022

Document Id: e1f6c055-e73c-b22a-e053-2995a90a5b12

34390-5

Set id: d5e1795b-2fc1-f099-e053-2a95a90ab9a0

Version: 2

Effective Time: 20220621