FDA.reportPublic FDA data

Australian Gold Botanical SPF 50 Continuous spray

Manufacturer
Prime Packaging, Inc. | Prime Enterprises, Inc.
Effective date
2024-05-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:03:53

Label at a glance#

ProductAustralian Gold Botanical 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

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 onto face. Spray on hands then apply to face do not apply in windy conditions use in a well-ventilated area reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures: Spending time in th...

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 - 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.

SPL UNCLASSIFIED SECTION

Flammable: Avoid fire, flame, heat or smoking. Contents under pressure. Do not puncture or incinerate. Store at temperatures below 120°F (50°C).

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 onto face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in a well-ventilated area
  • 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 decrease 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-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Glycerin, Fragrance, Water, Polyester-8, Tocopheryl Acetate, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Porphyra Umbilicalis Extract, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract

Other information

SPL UNCLASSIFIED SECTION

  • 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 (584-4653)

Australian Gold Botanical SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0167-42024-05-02C16284748780-11030e365-2b95-111a-e063-dadaa90a10e2Australian Gold Botanical SPF 50 Continuous spray
13630-0167-42024-01-30C16284748780-11030e365-2b95-111a-e063-dadaa90a10e2Australian Gold Botanical SPF 50 Continuous spray

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-022613630-0226-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
GLYCERINPDC6A3C0OXIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
PORPHYRA UMBILICALIS14AN0J70WOIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MIACT
VINYL ACETATEL9MK238N77IACT
DIBUTYL MALEATE4X371TMK9KIACT
ISOBORNYL ACRYLATEIX0PRH184PIACT
KAKADU PLUM0ZQ1D2FDLIIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
177d7a15-c47b-14bb-e063-6294a90ac9cdb066b408-e630-760c-e053-2995a90abcb62024-05-02WarningsExact identifier
spl id: 177d7a15-c47b-14bb-e063-6294a90ac9cd
spl set id: b066b408-e630-760c-e053-2995a90abcb6

Reported adverse events (FAERS/openFDA)#

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