FDA.reportPublic FDA data

Australian Gold

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

Label at a glance#

ProductAustralian Gold SPF 15 C/S Sunscreen with Bronzer
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

spray liberally and spread evenly by hand 15 minutes before sun exposure hold container 4 to 6 inches from the skin to apply do not spray directly into face. Spray on hands then apply to face do not apply in windy conditions use in a well-ventilated area 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 increas...

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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F

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.

SPL UNCLASSIFIED SECTION

Flammable: Do not use near heat, flame or while smoking.

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in a well-ventilated area
  • 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 INGREDIENT SECTION

Blue 1 (CI 42090), Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Glycerin, Polyester-8, Red 40 (CI 16035), SD Alcohol 40-B (Alcohol Denat.), Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water (Aqua), Yellow 5 (CI 19140)

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration

Question or comments?

OTC - QUESTIONS SECTION

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

Australian Gold SPF 15 C/S Sunscreen with Bronzer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0101-42023-01-30C16284748780-1f386c64a-3df3-0266-e053-dadaa90a7c1aAustralian Gold SPF 15 C/S Sunscreen with Bronzer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0101-4Australian GoldSPF 15 C/S Sunscreen with Bronzer240 mL in 1 CANSPRAY2402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0101AUSTRALIAN GOLD SPF 15 C/S SUNSCREEN WITH BRONZER (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]2Legacy NDC, 1 package rows20200118_28d816e7-3b9a-2014-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-010113630-0101-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
ALCOHOL3K9958V90MIACT
DIBUTYL MALEATE4X371TMK9KIACT
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
KAKADU PLUM0ZQ1D2FDLIIACT

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
9c5c3921-6c7e-7b53-e053-2995a90aa31e28d816e7-3b9a-2014-e054-00144ff88e882020-01-17WarningsExact identifier
spl id: 9c5c3921-6c7e-7b53-e053-2995a90aa31e
spl set id: 28d816e7-3b9a-2014-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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