Carmex Classic Lip Balm Medicated Spf 15 Salve
FDA Label NDC 10210-0023

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 Spf 15 (NDC 10210-0023). 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, when using this product:, stop use and ask a doctor if:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Camphor 1.70%

White Petrolatum 45.30%

Octinoxate 7.50%

Oxybenzone 4.00%

White Petrolatum 35.00%

Purpose

External Analgesic

Lip Protectant

Sunscreen

Lip Protectant

Uses

  • helps provide relief of symptoms of cold sores and dry lips
    • helps protect against sunburn and chapped lips
    • higher SPF gives more sunburn protection

Warnings

For external use only

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

When Using This Product:

keep out of eyes. Rinse with water to remove.

keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If:

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

    • rash occurs

Do Not Use

  • deep puncture wounds 
  • serious burns
  • animal bites

    • on damaged or broken skin

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply to lips not more than 3 to 4 times daily

• children under 2 years of age: ask a doctor 

• 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

• this is a personal care item, and should be used by one individual only

• protect this product from excessive heat and direct sun

• do not use if safety seal is broken prior to purchase

Inactive Ingredients

lanolin, beeswax, cetyl esters, paraffinum liquidum, theobroma cacao seed butter, menthol, salicylic acid, phenol, vanillin, flavor

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

Package Labeling:

Label4 (Label4)

Label4 (Label4)

* Please review the disclaimer below.