Non-nano Sunscreen
FDA Label NDC 72879-505

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Procaps Laboratories, Inc. for the product Non-nano Sunscreen (NDC 72879-505). 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, use, directions, other information, questions?, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 17.5%

Purpose

Sunscreen

Use

  • 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

  • For sunscreen use
  • apply liberally and evenly 15minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age: Ask a doctor.
  • Sun Protection Measures: Spending time in the sun increasesyour 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 measuresincluding
  • limit time in the sun, especially from 10 a.m.–2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

  • protect the product in this container from excessive heat and direct sun
  • may stain some fabrics

Questions?

CALL 800.800.1200
www.ProCapsLabs.com

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Silica, Coco-Glucoside, Microcrystalline Cellulose, Glycerin, Pyrus Malus (Apple) Fruit Extract, Cocoyl Proline, Humulus Lupulus (Hops) Extract, Isostearic Acid, Phenylpropanol, Polyhydroxystearic Acid, Xanthan Gum

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