Medichoice Moisturizing Lip Balm Spf15 Cream
FDA Label NDC 39892-0940

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by O&m Halyard, Inc. for the product Medichoice Moisturizing Lip Balm Spf15 (NDC 39892-0940). 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, stop use and ask a doctor if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients:

Avobenzone 3.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

  • For external use only

Do Not Use

  • on damaged or broken skin

Stop Use And Ask A Doctor If

  • rash occurs

When Using This Product

  • keep out of eyes. Rinse with water to remove.

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
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months of age: Ask a doctor 

    • Sun Protection MeasuresSpending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 

    • limit time in the sun, especially from 10a.m.-2p.m.
    • wear long sleeved shirts, pants hats, and sunglasses.

Inactive Ingredients:

Petrolatum, Mineral Oil, Paraffin Wax, Ozokerite Wax, Coconut Oil, Tocopherol, Soybean Oil.

Other Information

Protect this product from excessive heat and direct sun.

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