Carmex Daily Care Moisturizing Lip Balm Spf15 Broad Sprectrum Minis Kit
FDA Label NDC 10210-0067

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 Spf15 Broad Sprectrum Minis (NDC 10210-0067). 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

Drug Facts

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: • 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 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

Strawberry, Fresh Cherry, Wild Berry & Peach Mango 
petrolatum, lanolin, beeswax, cetyl esters, flavor, theobroma cacao (cocoa) seed butter, isopropyl palmitate, limnanthes alba (meadowfoam) seed oil, polypropylene, isohexadecane, polyamide-8, polyhydroxystearic acid, stevia rebaudiana extract

Cool Mint
petrolatum, lanolin, beeswax, cetyl esters, theobroma cacao (cocoa) seed butter, isopropyl palmitate, flavor, limnanthes alba (meadowfoam) seed oil, polypropylene, isohexadecane, polyamide-8, polyhydroxystearic acid, stevia rebaudiana extract

Package Labeling:

Kit3 (Kit3)

Kit3 (Kit3)

Kit4 (Kit4)

Kit4 (Kit4)

Package Labeling:Strawberry

Strawberry (Strawberry)

Strawberry (Strawberry)

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