Carmex Daily Care Moisturizing Lip Balm Spf 15 Assorted Kit
FDA Label NDC 10210-0082
Full FDA labeling including 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 Daily Care Moisturizing Lip Balm Spf 15 Assorted (NDC 10210-0082). 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, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Homosalate (7.0%)
Octocrylene (5.3%)
Octisalate (3.3%)
Avobenzone (2.4%)
Purpose
Sunscreen
Uses
- helps prevent sunburn
- 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
For external use only
Do Not Use
on damaged or broken skin
When Using This Product:
keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor If:
rash occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Posion Control Center right away.
Directions
• apply generously and evenly 15 minutes before sun exposure
• children under 6 months: Ask a doctor
• reapply: as needed or after towel drying, swimming or sweating
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 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
Inactve Ingredients
Wintergreen:petrolatum, lanolin, euphorbia cerifera (candelilla) wax, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, flavor, isopropyl palmitate, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract
Fresh Cherry, Strawberry:
petrolatum, lanolin, euphorbia cerifera (candelilla) wax, ozokerite, flavor, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, isopropyl palmitate, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract
Package Labeling:
Kit8 (Kit8)
Kit9 (Kit9)
Package Labeling:Strawberry
Strawberry (Strawberry)
Package Labeling:Wintergreen
Wintergreen (Wintergreen)
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