Winter Skin Protectant
FDA Label NDC 82177-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biomin Llc. for the product Winter Skin Protectant (NDC 82177-001). 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, 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

Zinc Oxide 20.00%

Allantoin 2%

Purpose

Sunscreen

Skin Protectant

Uses:

Temporarily protects and helps relieve chapped or chafed skin. Helps prevent and protect from the drying effects of wind and cold weather.

Warnings:

For external use only.

Do Not Use

  • on damaged or broken skin.
  • Do not use deep or puncture wounds animal bites serious burns.

Stop Use And Ask A Doctor

  • If rash occurs conditions worsens symptoms last more than 7 days or clear up again within a few days.

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 as needed. 
  • Children under 6 months of age: Ask a doctor.

Inactive Ingredients:

Cocos Nucifera (Coconut) Oil, Cera Alba (Beeswax), Calendula Officinalis (Calendula Flower) Infused in Simmondsia Chinensis (Jojoba Oil), Tocopherol (Vitamin E)

Other Information:

Protect this product from excessive heat and direct sun.

Package Labeling:

Label (Label)

Label (Label)

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