FDA.reportPublic FDA data

Australian Gold

Manufacturer
Prime Enterprises Inc.
Effective date
2022-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:02:16

Label at a glance#

ProductAustralian Gold Broad Spectrum SPF 50 Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and 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

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 Sun Protection Measures Spending time ine 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 valvue of 15 or higher and other sun protecion measures including: limit time in the...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Oxide 4%

Zinc Oxide 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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
  • Sun Protection Measures Spending time ine 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 valvue of 15 or higher and other sun protecion measures including:
  • limit time in the sun, especially from 10am-2pm
  • wear long sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Water, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Polymethylsilsesquioxane, PEG-10 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Dimethicone Crosspolymer, Fragrance, Stearic Acid, Phenoxyethanol, Alumina, Caprylyl Glycol, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Panthenol, Squalane, Disodium EDTA, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Porphyra Umbilicalis Extract, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract

Other Information

OTHER SAFETY INFORMATION

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

Questions or Comments?

OTC - QUESTIONS SECTION

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

Australian Gold Botanical Sunscreen Broad Spectrum SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-055158443-0551-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
STEARIC ACID4ELV7Z65APIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SQUALANEGW89575KF9IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
PORPHYRA UMBILICALIS14AN0J70WOIACT
GLYCERINPDC6A3C0OXIACT
KAKADU PLUM0ZQ1D2FDLIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
SHEA BUTTERK49155WL9YIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HEXYL LAURATE4CG9F9W01QIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
PANTHENOLWV9CM0O67ZIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ALUMINUM OXIDELMI26O6933IACT

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
ddcee338-4ea2-60bc-e053-2a95a90a5ca3ddcee338-4ea1-60bc-e053-2a95a90a5ca32022-04-29WarningsExact identifier
spl id: ddcee338-4ea2-60bc-e053-2a95a90a5ca3
spl set id: ddcee338-4ea1-60bc-e053-2a95a90a5ca3

Reported adverse events (FAERS/openFDA)#

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