FDA.reportPublic FDA data

Australian Gold SPF 30 Lip Balm

Manufacturer
Australian Gold | OraLabs
Effective date
2026-01-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:31

Label at a glance#

ProductAustralian Gold SPF 30 Lip Balm
Active ingredientPETROLATUM, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure7 sections

Indications and uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

Dosage and administration

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone, Homosalate, Octisalate, Petrolatum

Purpose

OTC - PURPOSE SECTION

Sunscreen, Skin Protectant

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

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 prevent sunburn, not skin cancer or early aging.

For external use only

Stop use and ask a doctor: If rash or irritation develops and lasts.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally before sun exposure and as needed.

Children under 6 months of age: Ask a doctor before use.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Australian Gold SPF 15
Australian Gold SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84061-126-01Australian Gold SPF 30 Lip Balm4.25 g in 1 CONTAINERSTICK4.252

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84061-12684061-126-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERESINQ1LS2UJO3AIACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
ISOCETYL STEARATE3RJ7186O9WIACT
PETROLATUM4T6H12BN9UACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
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
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Golde6877f7a-3aaa-4096-bcb5-eae0aa2532e52026-01-21WarningsExact identifier
ndc (package): 84061-126-01
ndc (product): 84061-126
ndc11 (package): 84061012601
spl id: 48efec8f-83dd-0744-e063-6394a90a0c29
spl set id: e6877f7a-3aaa-4096-bcb5-eae0aa2532e5

Reported adverse events (FAERS/openFDA)#

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