Australian Gold SPF 70 Plant Based Lotion Sunscreen

Australian Gold by

Drug Labeling and Warnings

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

Drug Details [pdf]

AUSTRALIAN GOLD SPF 70- avobenzone, homosalate, octisalate, octocrylene lotion 
Prime Enterprises, 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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Australian Gold SPF 70 Plant Based Lotion Sunscreen

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 5%

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, & sunglasses.
• Children under 6 months: Ask a doctor

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Water, Cocos Nucifera (Coconut) Oil, Glycerin, Styrene/Acrylates Copolymer, VP/Acrylates/Lauryl Methacrylate Copolymer, Phenoxyethanol, Tapioca Starch, Acrylic Acid/VP Crosspolymer, Fragrance (Parfum), Sodium Hydroxide, Caprylyl Glycol, Polyacrylate-13, Ethylhexylglycerin, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Polyisobutene, Polymethylsilsesquioxane, Polysorbate 20

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 Plant Based Lotion Sunscreen SPF 70

AUSTRALIAN GOLD  SPF 70
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0374
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.4 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	147 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)

Product Characteristics
Color	white (Off-White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0374-4	177 mL in 1 TUBE; Type 0: Not a Combination Product	12/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/11/2020

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	pack(58443-0374) , manufacture(58443-0374) , label(58443-0374) , analysis(58443-0374)

Revised: 1/2021

Document Id: b259c01f-bafb-713b-e053-2995a90a5e26

34390-5

Set id: b259c013-6cf9-8201-e053-2a95a90aa2c1

Version: 1

Effective Time: 20210105