FDA.reportPublic FDA data

ESSENTIAL DAILY SUNSCREEN

Manufacturer
ANTEDOTUM INC.
Effective date
2024-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:44:04

Label at a glance#

ProductESSENTIAL DAILY SUNSCREEN
Active ingredientZINC OXIDE
Label structure9 sections

Dosage and administration

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING. TO DECREASE THE RISK, REGULARLY USE A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TI...

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 10%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USE

INDICATIONS & USAGE SECTION

HELPS PREVENT SUNBURN

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 SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING. TO DECREASE THE RISK, REGULARLY USE 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.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, CETEARYL ALCOHOL, CETEARYL OLIVATE, POLYGLYCERYL-3 DIISOSTEARATE, SORBITAN OLIVATE, TOCOPHEROL, POPULUS TREMULOIDES (ASPEN) BARK EXTRACT, TETRAHEXYLDECYL ASCORBATE, CITRUS AURANTIUM AMARA (BITTER ORANGE)FLOWER OIL, HYDROLYZED PEA PROTEIN, GLYCERIN, GLUCOSE, CETEARYL GLUCOSIDE, TRIETHOXYCAPRYLYLSILANE, SODIUM CHLORIDE, SODIUM SUCCINATE, XANTHAN GUM, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, IRON OXIDES.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESSENTIAL DAILY SUNSCREENESSENTIAL DAILY SUNSCREEN

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82465-101ESSENTIAL DAILY SUNSCREEN (ZINC OXIDE) LOTION [ANTEDOTUM INC.]2Legacy NDC20241229_db000f96-dc46-4d4d-e053-2995a90a0c21.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82465-10182465-101-11, 82465-101-12, 82465-101-13, 82465-101-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POPULUS TREMULOIDES BARK5543O0CEIDIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
WATER059QF0KO0RIACT
CETEARYL OLIVATE58B69Q84JOIACT
CITRUS AURANTIUM FLOWER OILD4BGE91OXHIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
FERRIC OXIDE RED1K09F3G675IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM SUCCINATE HEXAHYDRATEU16QOD6C4EIACT
DIMETHICONE92RU3N3Y1OIACT
SORBITAN OLIVATEMDL271E3GRIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIB
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEA PROTEIN7Q50F46595IACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
4914bae4-1b5c-653b-e063-6394a90ae8f5db000f96-dc46-4d4d-e053-2995a90a0c212026-01-23WarningsExact identifier
spl set id: db000f96-dc46-4d4d-e053-2995a90a0c21

Reported adverse events (FAERS/openFDA)#

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