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 133 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b72d14-b69b-e9dd-e063-6394a90a748e2025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESCIENCE CEUTICALS, LLC369b20e2-2cad-e047-e063-6294a90a1bba2025-12-11Exact identifier
application number: M020
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b60880-5fe1-b78f-e063-6294a90a748d2025-12-11Exact identifier
application number: M020
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b51190-6a6d-c5e0-e063-6394a90ae8752025-12-11Exact identifier
application number: M020
Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC374fae34-41b9-4cab-e063-6394a90a9b1d2025-12-11Exact identifier
application number: M020
Z BlocZINC OXIDEThe Maui Medical Group, Inc34b64eb5-a91f-de43-e063-6294a90a80432025-12-11Exact identifier
application number: M020
Sheer Tinted Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6e8d0-6235-dac2-e063-6394a90afefd2025-12-11Exact identifier
application number: M020
Tinted Sunscreen Face PrimerTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY374f6b79-2ac4-61cf-e063-6394a90a699b2025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC375008f2-8dd4-aa31-e063-6394a90a5be82025-12-11Exact identifier
application number: M020
Replenishing Daily ProtectionZINC OXIDEThe Maui Medical Group, Inc34b96d82-7fcf-e452-e063-6394a90a781b2025-12-11Exact identifier
application number: M020
Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY LLC3750c2fd-c5cc-fd00-e063-6394a90aeb892025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC3750ffbf-a82d-b4b9-e063-6294a90a7d682025-12-11Exact identifier
application number: M020
The BlockZINC OXIDEELITE ESTHETICS BY NICOLE CAROLINE LLC34a6b17e-6e9e-3f2c-e063-6294a90a1c322025-12-11Exact identifier
application number: M020
SPF 40 Broad Spectrum Non-TintedZINC OXIDETeton Dermatology Holdings, Inc.35093797-008b-b265-e063-6294a90a99492025-12-11Exact identifier
application number: M020
Tinted Zinc ProtectionZINC OXIDETeton Dermatology Holdings, Inc.3508d5a8-9d3c-51d1-e063-6394a90abc8e2025-12-11Exact identifier
application number: M020
SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.35081ce0-2203-ab86-e063-6294a90aefd52025-12-11Exact identifier
application number: M020
Antioxidant SPFZINC OXIDETeton Dermatology Holdings, Inc.3509a916-f3e1-9c53-e063-6394a90a5bff2025-12-11Exact identifier
application number: M020
Ultimate Physical Sunscreen TintedZINC OXIDEHALEM DERMATOLOGY PLLC35bb4953-ca8c-e927-e063-6394a90a1a312025-12-11Exact identifier
application number: M020
Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.3509eea7-f966-2080-e063-6294a90aeeb52025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHALEM DERMATOLOGY PLLC35bce44e-d9f4-9279-e063-6394a90a64532025-12-11Exact 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