FDA.reportPublic FDA data

Australian Gold

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 50 Sunscreen
Active ingredientOCTOCRYLENE, AVOBENZONE, OCTISALATE, HOMOSALATE
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

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 Sun Protection Measures Spending time ine the sun increases your risk of skin cancer and early skin aging. ...

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

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
  • Sun Protection Measures Spending time ine 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 protecion measures including:
  • limit time in the sun, especially from 10am-2pm
  • wear long sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Caramel, Dimethicone, Ethylhexylglycerin, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate, Trimethylsiloxysilicate, Water

Other Information

OTHER SAFETY INFORMATION

  • Protect this product from excesive 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 INSTANT BRONZER Broad Spectrum SPF 50

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 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-057058443-0570-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYPROMELLOSES3NXW29V3WOIACT
OLIVE OIL6UYK2W1W1EIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
KAKADU PLUM0ZQ1D2FDLIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARAMELT9D99G2B1RIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
TEA TREE OILVIF565UC2GIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB

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
178eeda2-cdc4-a059-e063-6294a90a5d4fe819ab31-412d-5bed-e053-2a95a90a307d2024-05-03WarningsExact identifier
spl id: 178eeda2-cdc4-a059-e063-6294a90a5d4f
spl set id: e819ab31-412d-5bed-e053-2a95a90a307d

Reported adverse events (FAERS/openFDA)#

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