FDA.reportPublic FDA data

KARI GRAN ESSENTIAL SPF

Product NDC
73665-102
11-digit product format
736650102
Labeler code
73665
Product ID
73665-102_5d1c5688-cb8c-9320-e063-6394a90a62d6
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
KARI GRAN
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-16
Substance
ZINC OXIDE
Active strength
18 g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage73665-102-15
excluded packagepackage73665-102-51
excluded packagepackage73665-102-31

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
KARI GRAN ESSENTIAL SPF
Brand name suffix
SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE18 g/100mL

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, Related label table
NDCEffectiveRelated label
73665-102-152024-10-07KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-152024-10-07KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-312024-10-07KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-312024-10-07KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-512024-10-07KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-512024-10-07KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-152024-07-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-152024-07-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-312024-07-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-312024-07-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-512024-07-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-512024-07-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-152024-01-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-152024-01-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-312024-01-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-312024-01-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-512024-01-30KARI GRAN - ESSENTIAL SPF 30, TINTED AND UNTINTED - (73665-102)
73665-102-512024-01-30KARI 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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73665-102KARI GRAN ESSENTIAL SPF SPF 30 (ZINC OXIDE) SOLUTION [KARI GRAN]9Current NDC, Legacy NDC, 2 package rows20241009_caf07d84-d3f3-eef2-e053-2a95a90aa511.zip

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 114 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kind Restore Tinted Mineral SunscreenZINC OXIDEPOLISH BEAUTY3980d278-c0f4-2c59-e063-6394a90aac372025-12-16Exact identifier
application number: M020
Solar Eclipse Extreme SunscreenZINC OXIDEULTRAVIOLET SKINCARE LLC36bfa691-48c0-8033-e063-6294a90ad8992025-12-16Exact identifier
application number: M020
Kind Restore Moisturizing Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPOLISH BEAUTY39814e27-4f3f-5ee6-e063-6394a90a941b2025-12-16Exact identifier
application number: M020
Yoali SPF 40ZINC OXIDEYOALI STUDIO LLC390b7f9c-bc04-80ec-e063-6294a90a40922025-12-16Exact identifier
application number: M020
Skin Defense Matte Tinted SunscreenZINC OXIDEGentlehomme LLC365eb727-3e7f-f1dd-e063-6394a90aa4692025-12-16Exact identifier
application number: M020
Dr B Clinical Skin Care Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDENAIRA BABAIAN, M.D., P.A.365da1f8-5250-7589-e063-6294a90a3e682025-12-16Exact identifier
application number: M020
Dr B Clinical Skin Care Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDENAIRA BABAIAN, M.D., P.A.365d7564-3025-257b-e063-6294a90ad1702025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEGentlehomme LLC365e7d8e-e3e0-4c08-e063-6294a90af4152025-12-16Exact identifier
application number: M020
Daily Replenish mineral sunscreenZINC OXIDEPURE VITALITY SKIN AND BODY, INC369896b1-f4b4-6201-e063-6394a90a5bca2025-12-16Exact identifier
application number: M020
Zinc 20 mineral sunscreen face Plus bodyZINC OXIDEPURE VITALITY SKIN AND BODY, INC36985373-22dd-2232-e063-6394a90a76fb2025-12-16Exact identifier
application number: M020
Matte Defense Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698090a-1639-00f9-e063-6394a90a7dd12025-12-16Exact identifier
application number: M020
Daily Replenish mineral sunscreenZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698d309-b9bf-e197-e063-6294a90af5a12025-12-16Exact identifier
application number: M020
Zinc 20 mineral sunscreen face Plus bodyZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698f29e-5d80-94af-e063-6394a90a04892025-12-16Exact identifier
application number: M020
Tinted Mineral Primer SPF 40TITANIUM DIOXIDE, ZINC OXIDEJOSEPHINA RAMIREZ365cf2be-8862-3622-e063-6394a90ac4e32025-12-16Exact identifier
application number: M020
SANCTUARY Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECHAMPAGNE APOTHECARY LLC365ca99c-c878-1f4b-e063-6394a90a1f532025-12-16Exact identifier
application number: M020
Tinted Mineral Defense SPF 40ZINC OXIDEJOSEPHINA RAMIREZ365d299a-5886-5597-e063-6394a90a336c2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILL VALLEY DERMATOLOGY, INC.3b171a89-c757-47a1-e063-6294a90a7a642025-12-16WarningsExact identifier
application number: M020
Tinted BB CreamZINC OXIDEEco Esthetics LLC38f3e618-59e1-4504-e063-6394a90afa552025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEMADRE TIERRA, INC.3f697463-d3db-7b73-e063-6394a90ac2222025-12-16WarningsExact identifier
application number: M020
Non-Tinted Replenishing Daily ProtectionZINC OXIDEMADRE TIERRA, INC.3f69d6f3-454b-e60a-e063-6394a90a87812025-12-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73665-102-157366501021515 mL in 1 BOTTLE (73665-102-15) 15 ml2021-12-030000-00-00NoNoCurrent
73665-102-307366501023030 mL in 1 BOTTLE30 mlHistorical
73665-102-31736650102311 BOTTLE in 1 BOX (73665-102-31) / 30 mL in 1 BOTTLE (73665-102-30) 1 bottle2023-10-160000-00-00NoNoCurrent
73665-102-51736650102511 BOTTLE in 1 BOX (73665-102-51) > 50 mL in 1 BOTTLE (73665-102-50) 1 bottle2020-04-290000-00-00NoNoCurrent