FDA.reportPublic FDA data

Tea Tree Lip Balm, SPF 15

Manufacturer
OraLabs
Effective date
2025-04-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:59:52

Label at a glance#

ProductTea Tree Lip Balm, SPF 15
Active ingredientOCTINOXATE, OXYBENZONE
Label structure8 sections

Indications and uses

Prevents Sunburns

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

Octinoxate (2.0%), Oxybenzone (4.5%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

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

Prevents Sunburns

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Synthetic Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Flavor, Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts Panel - Formula L-BX TTM NPIG 15
Drug Facts Panel - Formula L-BX TTM NPIG 15

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63645-176-032025-04-28C16284748780-12cef2736-71ad-d83d-e063-dadaa90ab31fDrug Facts
63645-176-032025-01-30C16284748780-12cef2736-71ad-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-176-03Tea Tree Lip Balm, SPF 154 g in 1 CONTAINERSTICK43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-176TEA TREE LIP BALM, SPF 15 (OCTINOXATE, OXYBENZONE) STICK [ORALABS]3Current NDC, Legacy NDC, 1 package rows20250429_ce11b043-0290-4c18-afbc-df4e49656c31.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63645-17663645-176-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
WHITE WAX7G1J5DA97FIACT
ACETYLATED LANOLIN2X654GD19HIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB

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
Tea Tree Lip Balm, SPF 15OCTINOXATE, OXYBENZONEOraLabsce11b043-0290-4c18-afbc-df4e49656c312025-04-28WarningsExact identifier
ndc (package): 63645-176-03
ndc (product): 63645-176
ndc11 (package): 63645017603
spl id: 33dd4841-ac64-5d7a-e063-6394a90a4b98
spl set id: ce11b043-0290-4c18-afbc-df4e49656c31

Reported adverse events (FAERS/openFDA)#

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