FDA.reportPublic FDA data

Cremo All-Season Lip Balm SPF 25 Vanilla Mint

Manufacturer
Cremo Company
Effective date
2022-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:28

Label at a glance#

ProductCremo All-Season Lip Balm SPF 25 Vanilla Mint
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUM, OCTOCRYLENE
Label structure13 sections

Indications and uses

Helps Prevent sunburn and chapped lips.

Dosage and administration

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

Storage and handling

Protect product from excessive heat and direct sunlight. You may report a serious adverse reaction from using this product to Cremo Company at 1-800-853-1762.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

Petrolatum 40%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps Prevent sunburn and chapped lips.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

If rash occurs, discontinue use and consult a health care practitioner

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Theobroma Cacao (Cocoa) Seed Butter, Beeswax, Flavor, Polyglyceryl-3 Beeswax, Lanolin, C18-38 Alkyl Hydroxystearoyl Stearate, Hydrogenated Poly (C6-14 Olefin), Ethylene/Propylene/Styrene Copolymer, Butylene/Ethylene/Styrene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Cannabis Sativa Seed Oil*, Bisabolol, Tocopherol.
*Organic

Other Information

STORAGE AND HANDLING SECTION

Protect product from excessive heat and direct sunlight. You may report a serious adverse reaction from using this product to Cremo Company at 1-800-853-1762.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lip BalmLip BalmCremo All-Season Lip Balm SPF 25

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71825-120-612025-01-30C16284748780-12cef2736-64ed-d83d-e063-dadaa90ab31fLip Balm SPF 25 Vanilla Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71825-120-61Cremo All-Season Lip Balm SPF 25 Vanilla Mint7 g in 1 TUBEOINTMENT71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71825-120CREMO ALL-SEASON LIP BALM SPF 25 VANILLA MINT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, PETROLATUM) OINTMENT [CREMO COMPANY]1Legacy NDC, 1 package rows20220107_d4ec08df-8f36-8e0d-e053-2a95a90af728.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71825-12071825-120-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
C18-38 ALKYL HYDROXYSTEAROYL STEARATEWW4FVB2PEMIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
TOCOPHEROLR0ZB2556P8IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
COCOA BUTTER512OYT1CRRIACT
YELLOW WAX2ZA36H0S2VIACT
LEVOMENOL24WE03BX2TIACT
HOMOSALATEV06SV4M95SACTIB
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
d4ec08df-8f37-8e0d-e053-2a95a90af728d4ec08df-8f36-8e0d-e053-2a95a90af7282022-01-06WarningsExact identifier
spl id: d4ec08df-8f37-8e0d-e053-2a95a90af728
spl set id: d4ec08df-8f36-8e0d-e053-2a95a90af728

Reported adverse events (FAERS/openFDA)#

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