FDA.reportPublic FDA data

Australian Gold Broad Spectrum SPF 50 Sunscreen Lotion

Manufacturer
Prime Enterprises, Inc.
Effective date
2023-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:27:37

Label at a glance#

ProductAustralian Gold Broad Spectrum SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, 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 decease 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, e...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 5 %

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

OTHER SAFETY INFORMATION

For external use only

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash 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 decease 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 Ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Juice, Glycerin, Polyethylene, Phenoxyethanol, Fragrance, Polysorbate 20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomber, Sodium Hydroxide, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Allantoin, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Camellia Oleifera (Green Tea) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride

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)

Australian Gold Broad Spectrum SPF 50 Sunscreen Lotion - 237 mL

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 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-043758443-0437-9

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
POLYSORBATE 207T1F30V5YHIACT
COCOA BUTTER512OYT1CRRIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYPROMELLOSES3NXW29V3WOIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
TEA TREE OILVIF565UC2GIACT
KAKADU PLUM0ZQ1D2FDLIIACT
ALLANTOIN344S277G0ZIACT
SUNFLOWER OIL3W1JG795YIIACT
OLIVE OIL6UYK2W1W1EIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
SODIUM CHLORIDE451W47IQ8XIACT

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
021a20ce-df8b-d89b-e063-6394a90a89ef021a19b2-b1ae-ea8b-e063-6394a90a9a442023-08-04WarningsExact identifier
spl id: 021a20ce-df8b-d89b-e063-6394a90a89ef
spl set id: 021a19b2-b1ae-ea8b-e063-6394a90a9a44

Reported adverse events (FAERS/openFDA)#

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