Zinc Five-o
FDA Label NDC 80982-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Astivita Limited for the product Zinc Five-o (NDC 80982-001). 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 active ingredient, purpose, uses, warnings, directions:, inactive ingredients, questions or comments?, 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 25%

Purpose

SUNSCREEN

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun

Warnings

  • Avoid prolonged exposure in the sun.
  • Wear protective clothing-hats and sunglasses.
  • Do not swallow.
  • For external use only.
  • Avoid contact with eyes.
  • If a rash or irritation occurs discontinue use.

Directions:

  • Apply generously to all areas 20 minutes before sun exposure.
  • Reapply every 2 hours or after swimming.

Inactive Ingredients

Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA

Questions Or Comments?

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