Australian Gold Ultimate Hydration Lotion Sunscreen SPF 30

Manufacturer
Prime Enterprises, Inc.
Effective date
2021-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:21

Label at a glance#

ProductAustralian Gold SPF 30
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE
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 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, e...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 7.5%

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

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medial help or contact a Poison Control Center right away.

Directions

DISPOSAL AND WASTE HANDLING

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 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-sleeve shirts, pants, hats and sunglasses

children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, C12-15 Alkyl Benzoate, Glycerin, Polyethylene, Phenoxyethanol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Sodium Hydroxide, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Olea Europaea (Olive) Fruit Oil, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Ethylhexylglycerin, Allantoin, Aloe Barbadensis Leaf Juice, Camellia Oleifera (Green Tea) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract

Other information

SPL UNCLASSIFIED SECTION

Protect this product form 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 Ultimate Hydration Lotion Sunscreen SPF 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0382-32024-01-30C16284748780-11030e365-3dfe-111a-e063-dadaa90a10e2Australian Gold Ultimate Hydration Lotion Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0382-3Australian GoldSPF 30100 mL in 1 BOTTLELOTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0382AUSTRALIAN GOLD SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.]1Legacy NDC, 1 package rows20210401_b8405df8-a0bb-4951-e053-2a95a90abcfd.zip

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
58443-038258443-0382-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

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
b8405df8-a0bc-4951-e053-2a95a90abcfdb8405df8-a0bb-4951-e053-2a95a90abcfd2021-01-06WarningsExact identifier
spl id: b8405df8-a0bc-4951-e053-2a95a90abcfd
spl set id: b8405df8-a0bb-4951-e053-2a95a90abcfd

Reported adverse events (FAERS/openFDA)#

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