FDA.reportPublic FDA data

Australian Gold

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 21:27:38

Label at a glance#

ProductAustralian Gold Instant Bronzer Broad Spectrum SPF 4 Sunscreen
Active ingredientOCTOCRYLENE, AVOBENZONE
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 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#

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Glycerin, Butylphthalimide, Caramel, Phenoxyethanol, Fragrance, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Isopropylphthalimide, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Trimethoxysiloxysilicate, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Hydroxypropyl Methylcellulose, Ethylhexylglycerin, Sodium Hydroxide, Propylene Glycol, Sorbitan Oleate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cnacer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

OTC - DO NOT USE SECTION

Do not useon 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 doctorif 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.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1%

Octocrylene 1%

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 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

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 SPF 4 BROAD SPECTRUM Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display FrontPrincipal Display FrontPrincipal Display BackPrincipal Display Back

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
58443-063358443-0633-4

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
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYPROMELLOSES3NXW29V3WOIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
SUNFLOWER SEEDR9N3379M4ZIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
TEA TREE OILVIF565UC2GIACT
OLIVE OIL6UYK2W1W1EIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
CARAMELT9D99G2B1RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)78GX033D7IIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT

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
021ab50a-2829-3fcd-e063-6294a90a315e021ae757-1b40-44eb-e063-6294a90a905d2023-08-04WarningsExact identifier
spl id: 021ab50a-2829-3fcd-e063-6294a90a315e
spl set id: 021ae757-1b40-44eb-e063-6294a90a905d

Reported adverse events (FAERS/openFDA)#

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