Thermasun Zinxation Mineral Zinc Facial Sunscreen - Acne Prone Skin
FDA Label NDC 80982-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Astivita Limited for the product Thermasun Zinxation Mineral Zinc Facial Sunscreen - Acne Prone Skin (NDC 80982-002). 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 active ingredient, purpose, uses, warnings, directions, inactive ingredients, questions?, 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 (25.0% W/W)

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

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 doctor if rash occurs

Directions

• apply liberally and evenly 20 minutes before sun exposure
• reapply: After 40 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 this 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 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: ask a doctor

Inactive Ingredients

Aqua, coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxystearic acid, maltodextrin, matricaria chamomilla (German chamomile extract), phenylpropanol, propanediol, caprylyl glycol, tocopherol (vitamin e), ethylhexylglycerin, cetyl phospate, sodium chloride, disodium EDTA

Package Label.Principal Display Panel

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