FDA.reportPublic FDA data

ETHICAL ZINC NATURAL CLEAR ZINC SUNSCREEN

Manufacturer
ETHICAL ZINC PTY LTD
Effective date
2023-09-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:56:18

Label at a glance#

ProductETHICAL ZINC NATURAL CLEAR ZINC SUNSCREEN SPF-50
Active ingredientZINC OXIDE
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 22.00%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USE

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 SECTION

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

USA_40x134mmx100g_FINAL_OUTLINEUSA_40x134mmx100g_FINAL_OUTLINE

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72962-101-112025-01-30C16284748780-12cef2736-a95f-d83d-e063-dadaa90ab31fETHICAL ZINC - NATURAL CLEAR ZINC SUNSCREEN SPF-50 (72962-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72962-101-11ETHICAL ZINC NATURAL CLEAR ZINC SUNSCREENSPF-50100 mL in 1 TUBELOTION1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72962-101ETHICAL ZINC NATURAL CLEAR ZINC SUNSCREEN SPF-50 (ZINC OXIDE) LOTION [ETHICAL ZINC PTY LTD]6Legacy NDC, 1 package rows20230926_4a8046e3-ddf5-4d57-9dd7-62013fed4ea9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72962-10172962-101-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WHITE WAX7G1J5DA97FIACT
COCO-CAPRYLATE4828G836N6IACT
CASTOR OILD5340Y2I9GIACT
COCONUT OILQ9L0O73W7LIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
ISOSTEARIC ACIDX33R8U0062IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0635330b-8894-e407-e063-6394a90aa4de4a8046e3-ddf5-4d57-9dd7-62013fed4ea92023-09-25WarningsExact identifier
spl id: 0635330b-8894-e407-e063-6394a90aa4de
spl set id: 4a8046e3-ddf5-4d57-9dd7-62013fed4ea9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.