FDA.reportPublic FDA data

SPF 45 - 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 00:59:32

Label at a glance#

ProductSPF 45 - Lip Balm
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUM
Label structure8 sections

Indications and uses

Prevents Sunburns. Helps prevent wind burned and chapped lips.

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 t...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 3.0%, Octinoxate 7.5%, Octisalate 5.0%................Sunscreen, Petrolatum 40.0%...........Skin Protectant

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

Prevents Sunburns. Helps prevent wind burned and chapped 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 to prevent sunburn, skin cancer and/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 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. -2 p.m. • wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Mineral Oil, Ozokerite, Phenyl Trimethicone, Tocopherol

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts for SPF 45
Drug Facts for SPF 45

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63645-183-012025-04-22C16284748780-12cef2736-b2de-d83d-e063-dadaa90ab31fDrug Facts
63645-183-012025-01-30C16284748780-12cef2736-b2de-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-183-01SPF 45 - Lip Balm4 g in 1 CONTAINERSTICK42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-183SPF 45 - LIP BALM (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUM) STICK [ORALABS]2Current NDC, 1 package rows20250424_afd10abe-1e8b-4df8-9d8c-ef15266c510c.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
63645-18363645-183-01

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
LIGHT MINERAL OILN6K5787QVPIACT
CERESINQ1LS2UJO3AIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
PETROLATUM4T6H12BN9UACTIB

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
SPF 45 - Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMOraLabsafd10abe-1e8b-4df8-9d8c-ef15266c510c2025-04-22WarningsExact identifier
ndc (package): 63645-183-01
ndc (product): 63645-183
ndc11 (package): 63645018301
spl id: 3363a160-68b7-c576-e063-6294a90a8768
spl set id: afd10abe-1e8b-4df8-9d8c-ef15266c510c

Reported adverse events (FAERS/openFDA)#

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