FDA.reportPublic FDA data

Australian Gold Instant Bronzer SPF 8 Spray Gel Sunscreen

Manufacturer
Prime Enterprises Inc.
Effective date
2022-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:47:26

Label at a glance#

ProductAustralian Gold Instant Bronzer SPF 8 Sunscreen
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTISALATE
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%

Octisalate 3%

Octocrylene 2%

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

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

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 INSTANT BRONZER 8 SPRAY GEL SUNSCREEN

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 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-059358443-0593-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN MONOOLEATE06XEA2VD56IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)78GX033D7IIACT
DIMETHICONE92RU3N3Y1OIACT
HYPROMELLOSES3NXW29V3WOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
CARAMELT9D99G2B1RIACT
WATER059QF0KO0RIACT
SUNFLOWER OIL3W1JG795YIIACT
TEA TREE OILVIF565UC2GIACT
OLIVE OIL6UYK2W1W1EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

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
ee01026c-006b-f5c4-e053-2995a90adaefedff6f0d-fb77-9dbb-e053-2995a90a989c2022-11-21WarningsExact identifier
spl id: ee01026c-006b-f5c4-e053-2995a90adaef
spl set id: edff6f0d-fb77-9dbb-e053-2995a90a989c

Reported adverse events (FAERS/openFDA)#

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