Australian Gold Plant Based Lotion Sunscreen SPF 30

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 30- 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 Plant Based Lotion Sunscreen SPF 30

Active Ingredients

Avobenzone 3%, Homosalate 7.5%, 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 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

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Water/Aqua/Eau, Cocos Nucifera (Coconut) Oil, Glycerin, Tapioca Starch, VP/Acrylates/Lauryl Methacrylate Copolymer, Phenoxyethanol, 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 1-855-LIV-GOLD (548-4653)

Australian Gold Plant Based Lotion Sunscreen SPF 30

AUSTRALIAN GOLD  SPF 30
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0375
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.67 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	74.18 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49.45 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0375-4	177 mL in 1 TUBE; Type 0: Not a Combination Product	12/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/10/2020

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(58443-0375) , label(58443-0375) , analysis(58443-0375) , pack(58443-0375)

Revised: 1/2021

Document Id: b592a02c-048f-f4ae-e053-2995a90a7f93

34390-5

Set id: b592a02c-048e-f4ae-e053-2995a90a7f93

Version: 1

Effective Time: 20210105