Ethical Zinc Natural Clear Zinc Sunscreen
FDA Label NDC 72962-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ethical Zinc Pty Ltd for the product Ethical Zinc Natural Clear Zinc Sunscreen (NDC 72962-101). 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 ingredients, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

ZINC OXIDE 22.00%

Purpose

SUNSCREEN

Use

  • HELPS PREVENT SUNBURN.
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DECREASES THE RISK OF 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.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS 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
    • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

Inactive Ingredients

MEDIUM CHAIN TRIGLYCERIDES, WHITE BEESWAX, COCO-CAPRYLATE, CASTOR OIL, COCONUT OIL, POLYGLYCERYL-3 POLYRICINOLEATE, ISOSTEARIC ACID, D-ALPHA-TOCOPHERYL ACETATE, FRENCH VANILLA FRAGRANCE

Other Information

  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

Package Label.Principal Display Panel

Usa_40x134mmx100g_final_outline (Usa 40x134mmx100g Final Outline)

Usa_40x134mmx100g_final_outline (Usa 40x134mmx100g Final Outline)

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