FDA.reportPublic FDA data

Australian Gold Spray Oil Sunscreen Broad Spectrum SPF 4

Manufacturer
Prime Enterprises, Inc.
Effective date
2024-05-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:03:55

Label at a glance#

ProductAustralian Gold Broad Spectrum SPF 4
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 %

OTC - PURPOSE SECTION

Purpose

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

OTHER SAFETY INFORMATION

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 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

SPL UNCLASSIFIED SECTION

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

OTC - QUESTIONS SECTION

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display LabelPrinciple Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-045758443-0457-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
KAKADU PLUM0ZQ1D2FDLIIACT
CARROT SEED OIL595AO13F11IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETYL ACETATE4Q43814HXSIACT
ACETYLATED LANOLIN ALCOHOLSSNN716810PIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
SUNFLOWER OIL3W1JG795YIIACT
ISOPROPYL LINOLEATE4MW1E9AT4HIACT
TEA TREE OILVIF565UC2GIACT
COCONUT OILQ9L0O73W7LIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)AG75W62QYUIACT
AVOBENZONEG63QQF2NOXACTIB
TRICAPRINO1PB8EU98MIACT
OCTOCRYLENE5A68WGF6WMACTIB
KUKUI NUT OILTP11QR7B8RIACT

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
178ec3da-ec24-8948-e063-6294a90aefcdd21b7132-13fc-7991-e053-2a95a90a814a2024-05-03WarningsExact identifier
spl id: 178ec3da-ec24-8948-e063-6294a90aefcd
spl set id: d21b7132-13fc-7991-e053-2a95a90a814a

Reported adverse events (FAERS/openFDA)#

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