FDA.reportPublic FDA data

ETHICAL ZINC DAILY WEAR TINTED FACIAL SUNSCREEN

Manufacturer
ETHICAL ZINC PTY LTD
Effective date
2023-09-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:17

Label at a glance#

ProductETHICAL ZINC DAILY WEAR TINTED FACIAL SUNSCREEN DARK TINT 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.

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 22.70%

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

PURIFIED WATER, COCO CAPRYLATE/CAPRATE, MEDIUM CHAIN TRIGLYCERIDES, OCTYLDODECANOL, GLYCEROL, CETEARYL ALCOHOL, POLYGLYCERYL-3 POLYRICINOLEATE, PEG-30 DIPOLYHYDROXYSTEARATE, GLUCONOLACTONE, ISOSTEARIC ACID, SODIUM CHLORIDE, SODIUM BENZOATE, CETEARYL GLUCOSIDE, EDTA, XANTHAN GUM, IRON OXIDE

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Daily Wear Tinted Facial Sunscreen DarkDaily Wear Tinted Facial Sunscreen Dark

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72962-103-112025-01-30C16284748780-12cef2736-88c6-d83d-e063-dadaa90ab31fETHICAL ZINC (as PLD) - DAILY WEAR TINTED FACIAL SUNSCREEN SPF-50+ DARK (72962-103)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72962-103-11ETHICAL ZINC DAILY WEAR TINTED FACIAL SUNSCREENDARK TINT SPF-50100 g in 1 TUBELOTION1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72962-103ETHICAL ZINC DAILY WEAR TINTED FACIAL SUNSCREEN DARK TINT SPF-50 (ZINC OXIDE) LOTION [ETHICAL ZINC PTY LTD]21 package rows20230926_017bd43b-ad7d-7d7b-e063-6294a90a97b2.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72962-10372962-103-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
OCTYLDODECANOL461N1O614YIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
GLUCONOLACTONEWQ29KQ9POTIACT
ISOSTEARIC ACIDX33R8U0062IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
EDETIC ACID9G34HU7RV0IACT
XANTHAN GUMTTV12P4NEEIACT
FERRIC OXIDE RED1K09F3G675IACT
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
063230d0-7c6a-77d9-e063-6294a90a7b34017bd43b-ad7d-7d7b-e063-6294a90a97b22023-09-25WarningsExact identifier
spl id: 063230d0-7c6a-77d9-e063-6294a90a7b34
spl set id: 017bd43b-ad7d-7d7b-e063-6294a90a97b2

Reported adverse events (FAERS/openFDA)#

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