OraLabs SPF 15 Lip Balm

Manufacturer
OraLabs
Effective date
2025-04-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:59:31

Label at a glance#

ProductOraLabs SPF 15 Lip Balm
Active ingredientOCTINOXATE, AVOBENZONE, PETROLATUM
Label structure8 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 aging caused by the sun. helps prevent and temporarily protects chafed, chapped or cracked lips. Helps prevent and protect from the drying effects of wind and cold weather

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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the s...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (3.0%), Octinoxate (7.5%)

Petrolatum (42.3%)

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. if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early aging caused by the sun. helps prevent and temporarily protects chafed, chapped or cracked lips. Helps prevent and protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only: Do not use on damaged or broken skin. When using this product. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor: if rash occurs

Directions

DOSAGE & ADMINISTRATION SECTION

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 the 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. to 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Beeswax, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Isopropyl Lanolate, Lanolin, Parraffin, Saccharin, Tocopheryl Acetate, Tocerpheryl Linoleate/Oleate.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ChapIce SPF 15 Lip Balm
ChapIce SPF 15 Lip Balm

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63645-181-032025-04-22C16284748780-12cef2736-9ab0-d83d-e063-dadaa90ab31fDrug Facts
63645-181-032025-01-30C16284748780-12cef2736-9ab0-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-181-03OraLabs SPF 15 Lip Balm4.25 g in 1 CONTAINERSTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-181ORALABS SPF 15 LIP BALM (AVOBENZONE, OCTINOXATE, PETROLATUM) STICK [ORALABS]2Current NDC, Legacy NDC, 1 package rows20250424_3ac8569f-4b11-4536-8919-234f79bbd7fc.zip

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
63645-18163645-181-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
OraLabs SPF 15 Lip BalmAVOBENZONE, OCTINOXATE, PETROLATUMOraLabs3ac8569f-4b11-4536-8919-234f79bbd7fc2025-04-22WarningsExact identifier
ndc (package): 63645-181-03
ndc (product): 63645-181
ndc11 (package): 63645018103
spl id: 3365a012-e546-2e6f-e063-6394a90ab1fb
spl set id: 3ac8569f-4b11-4536-8919-234f79bbd7fc

Reported adverse events (FAERS/openFDA)#

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