FDA.reportPublic FDA data

KARI GRAN ESSENTIAL SPF

Manufacturer
KARI GRAN
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:26:57

Key Label Information#

Active Ingredients And Purpose

ACTIVE INGREDIENT

NON-NANO ZINC OXIDE 18%

PURPOSE

SUNSCREEN

Uses

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.

Warnings

WARNINGS

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.

Directions And Dosage

DIRECTIONS

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

Other Label Information

INACTIVE INGREDIENTS

UNTINTED: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+ TINTED, LIGHT: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica. TINTED, MEDIUM: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica. TINTED, DARK: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica, Ultramarines. *certified organic +non-GMO Vitamin E from Sunflower ++ non-GMO

STORAGE AND HANDLING SECTION

KEEP THIS PRODUCT AWAY FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT

QUESTIONS OR COMMENTS?

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

Label Images#

0-UC_Essential SPF-30
0-UC_Essential SPF-30
0-Image_Essential SPF-30
0-Image_Essential SPF-30

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
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73665-102-152024-10-07C16284748780-11030e365-5a77-111a-e063-dadaa90a10e2KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-312024-10-07C16284748780-11030e365-5a77-111a-e063-dadaa90a10e2KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-512024-10-07C16284748780-11030e365-5a77-111a-e063-dadaa90a10e2KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-152024-07-30C16284748780-11030e365-5a77-111a-e063-dadaa90a10e2KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-312024-07-30C16284748780-11030e365-5a77-111a-e063-dadaa90a10e2KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-512024-07-30C16284748780-11030e365-5a77-111a-e063-dadaa90a10e2KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-152024-01-30C16284748780-11030e365-5a77-111a-e063-dadaa90a10e2KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-312024-01-30C16284748780-11030e365-5a77-111a-e063-dadaa90a10e2KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-512024-01-30C16284748780-11030e365-5a77-111a-e063-dadaa90a10e2KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73665-102-30KARI GRAN ESSENTIAL SPFSPF 3030 mL in 1 BOTTLESOLUTION3010
73665-102-31KARI GRAN ESSENTIAL SPFSPF 301 in 1 BOXSOLUTION110

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73665-10273665-102-30, 73665-102-31

Ingredients#

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPIACT
MICAV8A1AW0880IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ULTRAMARINE BLUEI39WR998BIIACT
KUKUI NUT OILTP11QR7B8RIACT
RASPBERRY SEED OIL9S8867952AIACT
PLUM SEED OIL67EIU8N086IACT
MACADAMIA OIL515610SU8CIACT
AVOCADO OIL6VNO72PFC1IACT
JOJOBA OIL724GKU717MIACT
YELLOW WAX2ZA36H0S2VIACT
TOCOPHEROLR0ZB2556P8IACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIM

Complete SPL Sections#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

NON-NANO ZINC OXIDE 18%

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

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: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+ TINTED, LIGHT: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica. TINTED, MEDIUM: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica. TINTED, DARK: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica, Ultramarines. *certified organic +non-GMO Vitamin E from Sunflower ++ non-GMO

STORAGE AND HANDLING SECTION

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)

Source Document#

Source XML