Wax Spf 50
FDA Label NDC 82177-002

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 Wax Spf 50 (NDC 82177-002). 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. Helps prevent sunburn. Higher SPF gives more sunburn protection.

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 liberally 15 minutes before sun exposure and as needed. Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every two hours.
  • Children under 6 months of age: Ask a doctor.

    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

Simmondsia Chinensis (Jojoba) Seed Oil, Jojoba Esters, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Argania Spinosa Kernel Oil (Argan Oil), Tocopherol, Bisabolol, Calcium Silicate, Phytosteryl/Behenyl/Octyldodecyl Lauroyl Glutamate, Oryza Sativa (Rice) Bran Oil, Oryza Sativa (Rice) Bran Wax, Rhus Succedanea Fruit Wax, Helianthus Annuus (Sunflower) Seed Oil

Other Information:

Protect this product from excessive heat and direct sun.

Package Labeling:

Label2 (Label2)

Label2 (Label2)

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