FDA.reportPublic FDA data

Designer Lip Smoothie SPF 15 Lip Balm

Manufacturer
Australian Gold | OraLabs
Effective date
2026-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:28

Label at a glance#

ProductDesigner Lip Smoothie SPF 15 Lip Balm
Active ingredientOCTISALATE, AVOBENZONE, PETROLATUM, HOMOSALATE
Label structure8 sections

Indications and uses

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

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months: Ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (3.0%), Homosalate (8.0%), Octisalate (5.0%)

Petrolatum (38.8%)

Purpose

OTC - PURPOSE SECTION

Sunscreen, 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 protect dry, chapped, or windburned lips.

Warnings

WARNINGS SECTION

For external use only: When using this product. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut ) Oil, Ethylhexyl Methoxycrylene, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Microcrystalline Wax, Olea Europaea (Olive) Fruit Oil, Ozokerite, Saccharin, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lip Smoothie SPF 15
Lip Smoothie SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84061-127-01Designer Lip Smoothie SPF 15 Lip Balm3.12 g in 1 CONTAINERSTICK3.121

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
84061-12784061-127-01

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
ISOCETYL STEARATE3RJ7186O9WIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
PETROLATUM4T6H12BN9UACTIB
HOMOSALATEV06SV4M95SACTIB

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
Designer Lip Smoothie SPF 15 Lip BalmAVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUMAustralian Gold6fd1bd4f-ef94-42b5-a26c-2a02718c113f2026-01-22WarningsExact identifier
ndc (package): 84061-127-01
ndc (product): 84061-127
ndc11 (package): 84061012701
spl id: 4902047b-0049-6572-e063-6394a90a23df
spl set id: 6fd1bd4f-ef94-42b5-a26c-2a02718c113f

Reported adverse events (FAERS/openFDA)#

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