Carmex Sun Moisturizing Lip Balm Spf 30 Salve
FDA Label NDC 10210-0100

10 label sections · Submitted to the FDA by Carma Laboratories, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carma Laboratories, Inc. for the product Carmex Sun Moisturizing Lip Balm Spf 30 (NDC 10210-0100). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor if :, 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

Drug Facts

Active Ingredients

Avobenzone (3.0%) 
Octisalate (5.0%) 
Octocrylene (10.0%) 

Purpose

Sunscreen

Uses

• helps prevent sunburn and chapped lips
• higher SPF gives more sunburn protection
• provides moderate protection against sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

Do Not Use

on damaged or broken skin

Stop Use And Ask A Doctor If :

rash occurs

Keep Out Of Reach Of Children

Directions

• apply generously
• reapply: • 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 this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 am – 2 pm
• wear long-sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

petrolatum, beeswax, euphorbia cerifera (candelilla) cera, theobroma cacao (cocoa) seed butter, cetyl esters, lanolin, flavor, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract, tocopherol (vitamin E)

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