Carmex Classic Lip Balm Medicated Spf15 Triple Force Formula Salve
FDA Label NDC 10210-0066

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 Classic Lip Balm Medicated Spf15 Triple Force Formula (NDC 10210-0066). 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

Octinoxate 7.50%
Oxybenzone 4.00%
White Petrolatum 35.00%

Purpose

Sunscreen

Suncreen

Lip Protectant

Uses

  • helps protect against sunburn and chapped lips
  • higher SPF gives more sunburn protection

Warnings

Skin Cancer/Skin Aging Alert:Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply: at least every 2 hours
  • children under 2 years of age: ask a doctor

Other Information

  • this is a personal care item, and should be used by one individual only
  • protect this product from excessive heat and direct sun

Inactive Ingredients

lanolin, theobroma cacao seed butter, euphorbia cerifera wax, beeswax, cetyl esters, ozokerite, paraffin, limnanthes alba seed oil, camphor, menthol, salicylic acid, phenol, flavor, vanillin

10210-0066-1

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