FDA.reportPublic FDA data

Australian Gold

Manufacturer
Prime Enterprises Inc.
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:17

Label at a glance#

ProductAustralian Gold Broad Spectrum SPF 4 Sunscreen
Active ingredientAVOBENZONE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1%

Octocrylene 0.85%

Oxybenzone 0.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • 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 INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Disodium EDTA, Fragrance (Parfum), Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyethylene, Polysilicone-15, Polysorbate 20, Propylene Glycol, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other Information

OTHER SAFETY INFORMATION

  • protect this product from excesive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

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

Australian Gold Broad Spectrum SPF 4 Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0220-42024-01-30C16284748780-11030e365-2318-111a-e063-dadaa90a10e2Australian Gold Broad Spectrum SPF 4 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0220-4Australian GoldBroad Spectrum SPF 4 Sunscreen237 mL in 1 BOTTLELOTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0220AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 SUNSCREEN (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200121_29115ae7-413a-4b07-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-022058443-0220-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GIACT
COCOA BUTTER512OYT1CRRIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSES3NXW29V3WOIACT
OLIVE OIL6UYK2W1W1EIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
CARBOMER 9404Q93RCW27EIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
SUNFLOWER OIL3W1JG795YIIACT
ALOE VERA LEAFZY81Z83H0XIACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
KAKADU PLUM0ZQ1D2FDLIIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
TROLAMINE9O3K93S3TKIACT
POLYSILICONE-15F8DRP5BB29IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9c58daad-3808-a602-e053-2a95a90a2f9329115ae7-413a-4b07-e054-00144ff88e882020-01-17WarningsExact identifier
spl id: 9c58daad-3808-a602-e053-2a95a90a2f93
spl set id: 29115ae7-413a-4b07-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.