FDA.reportPublic FDA data

Australian Gold

Manufacturer
Prime Enterprises Inc.
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:44:27

Label at a glance#

ProductAustralian Gold SPF 15 Sheer Coverage Sunscreen
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
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 in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially f...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Octisalate 5%

Octocrylene 1.85%

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 - STOP USE 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 in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen 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-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Disodium EDTA, Fragrance (Parfum), Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Water (Aqua)

Other Information

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

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

Australian Gold SPF 15 Sheer Coverage Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

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
58443-017758443-0177-4

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
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
STEARYL ALCOHOL2KR89I4H1YIACT
LICORICE61ZBX54883IACT
CETYL ALCOHOL936JST6JCNIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
KAKADU PLUM0ZQ1D2FDLIIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
POLYSILICONE-15F8DRP5BB29IACT
EDETATE DISODIUM7FLD91C86KIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
ded2845b-bf6a-275f-e053-2a95a90a5a922b70d706-35b0-29da-e054-00144ff8d46c2022-05-12WarningsExact identifier
spl set id: 2b70d706-35b0-29da-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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