Clearchoice Sport Shield
FDA Label NDC 83722-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermastart Inc. for the product Clearchoice Sport Shield (NDC 83722-000). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 12%

Purpose

Sunscreen

Uses

  • helps prevent 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

Do Not Use

  • on damaged or broken skin

When Using This Product

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

Stop Use And Ask A Doctor If

  • rash occurs

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
  • 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 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 10a.m.-2p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information

  • protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Organic Aloe Vera, Thioctic Acid, Magnesium Ascorbyl Phosphate, Panthenol, Dexpanthenol, Tocopheryl Acetate, Ergocalciferol, Grape Seed Extract, Evening Primrose Oil, Sunflower Seed Oil, Safflower Seed Oil, Slippery Elm Extract, Borage Seed Oil, Alpha Bisabolol, Plantain, Allantoin, Hyaluronic Acid, Olive Squalane.

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