Active Ingredients
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 8%
Petrolatum 40%
Cremo All-season Lip Balm Spf 25 Vanilla Mint
FDA Label NDC 71825-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cremo Company for the product Cremo All-season Lip Balm Spf 25 Vanilla Mint (NDC 71825-120). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Skin Protectant
Uses
Helps Prevent sunburn and chapped lips.
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
If rash occurs, discontinue use and consult a health care practitioner
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical treatment help or contact a Poison Control Center right away.
Directions
Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months, consult a doctor.
Inactive Ingredients
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
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.
Questions?
1-800-853-1762 www.cremocompany.com
Package Label.Principal Display Panel
Cremo All-Season Lip Balm SPF 25
* Please review the disclaimer below.
