FDA.reportPublic FDA data

KARI GRAN ESSENTIAL SPF

Manufacturer
KARI GRAN
Effective date
2021-09-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:36:56

Label at a glance#

ProductKARI GRAN ESSENTIAL SPF SPF 28
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

HELPS PREVENT SUNBURN IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

Dosage and administration

SHAKE WELL. APPLY AT LEAST 1 PUMP TO FACE. APPLY ADDITIONAL PUMPS TO NECK AND CHEST - AREAS THAT ARE OFTEN IGNORED. APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY 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 OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES...

Storage and handling

KEEP THIS PRODUCT AWAY FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

NON-NANO ZINC OXIDE

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • HELPS PREVENT SUNBURN
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN 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, SEEK MEDICAL ATTENTION OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • SHAKE WELL. APPLY AT LEAST 1 PUMP TO FACE. APPLY ADDITIONAL PUMPS TO NECK AND CHEST - AREAS THAT ARE OFTEN IGNORED.
  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • REAPPLY 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 OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
  •       LIMIT TIME IN THE SUN, ESPECIALLY BETWEEN 10 A.M. AND 2 P.M.
  •       WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES
  • CHILDREN UNDER 6 MONTHS: CONSULT A PHYSICIAN

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

UNTINTED:  NON-GMO RUBUS IDEAUS (RED RASPBERRY SEED) OIL, NON-GMO PRUNUS DOMESTICA (FRENCH PLUM SEED) OIL, ORGANIC MACADAMIA TERNIFOLIA (MACADAMIA NUT SEED) OIL, NON-GMO ALEURITES MOLUCCANA (KUKUI SEED) OIL, ORGANIC PERSEA GRATISSIMA (AVOCADO) OIL, ORGANIC SIMMONDSIA CHINENSIS (JOJOBA SEED) OIL, ORGANIC BEESWAX, TOCOPHEROL (NON-GMO VITAMIN E FROM SUNFLOWER).

TINTED: NON-GMO RUBUS IDEAUS (RED RASPBERRY SEED) OIL, NON-GMO PRUNUS DOMESTICA (FRENCH PLUM SEED) OIL, ORGANIC MACADAMIA TERNIFOLIA (MACADAMIA NUT SEED) OIL, NON-GMO ALEURITES MOLUCCANA (KUKUI SEED) OIL, ORGANIC PERSEA GRATISSIMA (AVOCADO) OIL, ORGANIC SIMMONDSIA CHINENSIS (JOJOBA SEED) OIL, ORGANIC BEESWAX, TOCOPHEROL (NON-GMO VITAMIN E FROM SUNFLOWER).
MAY CONTAIN Titanium Dioxide, Yellow Iron Oxide, Mica, Iron Oxides, Brown Iron Oxide, Sericite Mica, Ultramarine Blue

STORAGE AND HANDLING SECTION

KEEP THIS PRODUCT AWAY FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

CALL MONDAY THROUGH FRIDAY, 206-588-1573 (9 A.M. TO 5 P.M. PST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kari Gran SPF 30mL Box DielinesKari Gran SPF 30mL Box Dielines

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73665-10173665-101-15, 73665-101-30, 73665-101-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
RASPBERRY SEED OIL9S8867952AIACT
PLUM SEED OIL67EIU8N086IACT
MACADAMIA OIL515610SU8CIACT
KUKUI NUT OILTP11QR7B8RIACT
AVOCADO OIL6VNO72PFC1IACT
JOJOBA OIL724GKU717MIACT
YELLOW WAX2ZA36H0S2VIACT
TOCOPHEROLR0ZB2556P8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MICAV8A1AW0880IACT
BROWN IRON OXIDE1N032N7MFOIACT
ULTRAMARINE BLUEI39WR998BIIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML · Source PDF

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
04dd80b6-cc52-f2e1-e063-6394a90aaaf5f044b64f-ab9e-4595-8867-63244e9669442023-09-08WarningsExact identifier
spl set id: f044b64f-ab9e-4595-8867-63244e966944

Reported adverse events (FAERS/openFDA)#

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