FDA.reportPublic FDA data

KELSEN - UNDER THE SUN BROAD SPECTRUM

Manufacturer
KELSEN PRODUCTS INC
Effective date
2024-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:11:58

Label at a glance#

ProductKELSEN - UNDER THE SUN BROAD SPECTRUM SPF 50 MINERAL 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 30%

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

Caprylic/Capric Triglyceride, Beeswax, Montmorillonite, Lanolin, Theobroma Cacao (Cocoa) Seed Butter, Theobroma Cacao (Cocoa) Powder, Tocopherol, Triethoxycaprylylsilane, Iron Oxides.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

BaseBase

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82626-102KELSEN - UNDER THE SUN BROAD SPECTRUM SPF 50 MINERAL SUNSCREEN (ZINC OXIDE) PASTE [KELSEN PRODUCTS INC]2Legacy NDC20240202_ef1cfeb7-4b99-beaf-e053-2995a90a3d79.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
82626-10282626-102-11, 82626-102-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
YELLOW WAX2ZA36H0S2VIACT
MONTMORILLONITEA585MN1H2LIACT
LANOLIN7EV65EAW6HIACT
COCOA BUTTER512OYT1CRRIACT
COCOAD9108TZ9KGIACT
TOCOPHEROLR0ZB2556P8IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
FERRIC OXIDE RED1K09F3G675IACT
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
490467f4-7574-5559-e063-6294a90a3c5bef1cfeb7-4b99-beaf-e053-2995a90a3d792026-01-22WarningsExact identifier
spl set id: ef1cfeb7-4b99-beaf-e053-2995a90a3d79

Reported adverse events (FAERS/openFDA)#

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