FDA.reportPublic FDA data

Australian Gold

Manufacturer
Prime Packaging, Inc. | Prime Enterprises, Inc.
Effective date
2020-09-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:13:54

Label at a glance#

ProductAustralian Gold SPF 30 with insect repellent
Active ingredientOXYBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

shake well before use apply liberally 15 minutes before sun exposure and rub into skin 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

Octinoxate 7.5%

Octisalate 5%

Octocrylene 5%

oxybenzone 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

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 away from face to avoid breathing it. 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 swalowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Flammable: Avoid fire, flame heat and smoking. Contents under pressure. Do not puncture or incinerate. Store at temperatures below 130°F.

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early sking aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • apply liberally 15 minutes before sun exposure and rub into skin
  • 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 ingredients

INACTIVE INGREDIENT SECTION

Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Extract, Ethyl Butylacetylaminopropionate, Fragrance, Glycine Soja (Soybean) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, SD Alcohol 40-B, Tocopheryl Acetate

Other information

SPL UNCLASSIFIED SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-885-548-4653

AUSTRALIAN GOLD SPF 30 CONTINUOUS SPRAY SUNSCREEN with Insect Repellent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-016213630-0162-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYBENZONE95OOS7VE0YACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SOYBEAN OIL241ATL177AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MIACT
TEA TREE OILVIF565UC2GIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ETHYL BUTYLACETYLAMINOPROPIONATE65GQA237EHIACT
OCTOXYNOL-78419DEW37JIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT

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
b00129f7-945f-1047-e053-2995a90a65e5b00122a7-2106-7a42-e053-2a95a90a6ee82020-09-23WarningsExact identifier
spl id: b00129f7-945f-1047-e053-2995a90a65e5
spl set id: b00122a7-2106-7a42-e053-2a95a90a6ee8

Reported adverse events (FAERS/openFDA)#

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