FDA.reportPublic FDA data

KELSEN - SPF 30

Manufacturer
KELSEN PRODUCTS 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#

ProductKELSEN - SPF 30 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. USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY 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 MEAS...

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.
  • USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • REAPPLY 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.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, BUTYLENE GLYCOL, CETEARYL ALCOHOL, CETEARYL OLIVATE, POLYGLYCERYL-3 DIISOSTEARATE, CETEARYL GLUCOSIDE, SORBITAN STEARATE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, XANTHAN GUM, CAMELLIA SINENSIS (GREEN TEA) LEAF OIL, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, IRON OXIDES.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KELSEN SPF 30 DAILY SUNSCREENKELSEN SPF 30 DAILY SUNSCREEN

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82626-101KELSEN - SPF 30 DAILY SUNSCREEN (ZINC OXIDE) LOTION [KELSEN PRODUCTS INC]2Legacy NDC20241229_db9f8cc5-b338-3b45-e053-2a95a90a1e23.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82626-10182626-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN OLIVATEMDL271E3GRIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETEARYL OLIVATE58B69Q84JOIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
FERRIC OXIDE RED1K09F3G675IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ZINC OXIDESOI2LOH54ZACTIB

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
491599b6-c125-94dd-e063-6394a90ad719db9f8cc5-b338-3b45-e053-2a95a90a1e232026-01-23WarningsExact identifier
spl set id: db9f8cc5-b338-3b45-e053-2a95a90a1e23

Reported adverse events (FAERS/openFDA)#

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