Carmex Weather Guard Moisturizing Lip Balm Spf 30 Salve
FDA Label NDC 10210-0056

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 Weather Guard Moisturizing Lip Balm Spf 30 (NDC 10210-0056). 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%

Avobenzone (3.0%)

Homosalate (10.0%)

Octisalate (5.0%)

Octocrylene (9.0%)

White Petrolatum (31.0%)

Purpose

External Analgesic

Lip Protectant

Sunscreen

Sunscreen

Lip Protectant

Uses

  • helps provide relief of symptoms of cold sores and dry lips
    • helps protect against sunburn
    • higher SPF gives more sunburn protection
      • helps prevent sunburn
      • hepls protect against the drying effects of wind 
      • high 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

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

    rash occurs

Do Not Use

  • deep puncture wounds 
  • serious burns
  • animal bites

    • on damaged or broken skin

    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.

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: • after 80 minutes of swimming or sweating

• immediately after towel drying • at least every 2 hours

• children under 2 years of age: ask a doctor

  • 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

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

petrolatum, lanolin, euphorbia cerifera cera, isopropyl palmitate, ozokerite, flavor, beeswax, cetyl esters, paraffin, theobroma cacao seed butter, limnanthes alba seed oil, stevia rebaudiana extract

euphorbia cerifera cera, ozoketite, flavor, paraffin, beeswax, Theobroma cacao seed butter, cetyl esters, lanolin, limnanthes alba seed oil, stevia rebaudiana extract

Package Labeling:

Label5 (Label5)

Label5 (Label5)

* Please review the disclaimer below.