FDA.reportPublic FDA data

Australian Gold Hydrating spray Oil SPF 4 Sunscreen

Manufacturer
Prime Enterprises Inc.
Effective date
2020-08-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:14:23

Label at a glance#

ProductAustralian Gold SPF 4 Sunscreen
Active ingredientAVOBENZONE, 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 • hold container 4 to 6 inches from the skin to apply • do not spray directly into face. Spray on hands then apply to face • 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 1%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

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 help 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 away from face to avoid breathing it. 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

  • shake well before use • apply liberally 15 minutes before sun exposure and rub into skin • hold container 4 to 6 inches from the skin to apply • do not spray directly into face. Spray on hands then apply to face • 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

Acetylated Lanolin Alcohol, Aleurites Moluccana Seed Oil, Aloe Barbadensis Leaf Extract, BHT, Caprylic/Capric Triglyceride, Cetyl Acetate, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Seed Oil, Diethylhexyl Syringylidene-Malonate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Lanolate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Terminalia Ferdinandiana (Kakadu Plum) Seed Oil, Tocopheryl Acetate, VP/Hexadecene Copolymer

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 SPF 4 SPRAY OIL

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 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-034858443-0348-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
CARROT SEED OIL595AO13F11IACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
ISOPROPYL LINOLEATE4MW1E9AT4HIACT
KUKUI NUT OILTP11QR7B8RIACT
OLIVE OIL6UYK2W1W1EIACT
HEXADECENE (MIXED ISOMERS)38H8547VP0IACT
ACETYLATED LANOLIN ALCOHOLSSNN716810PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
SUNFLOWER OIL3W1JG795YIIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CETYL ACETATE4Q43814HXSIACT
TEA TREE OILVIF565UC2GIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PYRROLIDONEKKL5D39EOLIACT
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
e9a8c0d3-6ec3-2fe5-e053-2995a90aea4dadb59353-7db0-73e6-e053-2a95a90aa2c22022-09-27WarningsExact identifier
spl set id: adb59353-7db0-73e6-e053-2a95a90aa2c2

Reported adverse events (FAERS/openFDA)#

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