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 112 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
application number: M020
Avail Body with SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEEmeis Cosmetics Pty Ltd4bb39ea1-f948-4357-b425-0cafd454ce302025-12-17WarningsExact identifier
application number: M020
Bronzing Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef749af07-0fcd-4376-be62-7c078b3e7eb62025-12-17WarningsExact identifier
application number: M020
Miffy Tone Perfecting SPF CushionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDERBGROUP Co., Ltd98a2906d-61e2-4627-a695-a20f10872f9a2025-12-16WarningsExact identifier
application number: M020
Dear Sun Tone Perfecting SPF CushionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDERBGROUP Co., Ltd80748647-e0ea-46dc-8ee2-a0ad77c4b19d2025-12-16WarningsExact identifier
application number: M020
SUNSCREEN StickZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%Foshan Sugar Max Cosmetics CO.,Ltd460e1038-30f0-a6e4-e063-6394a90ad5342025-12-16WarningsExact identifier
application number: M020
SUNSCREEN SPRAY150mlZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd460ead6c-dd44-e320-e063-6294a90a2b642025-12-16WarningsExact identifier
application number: M020
Sunscreen CreamZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%Foshan Sugar Max Cosmetics CO.,Ltd460f0ca0-9440-9a6e-e063-6394a90a33b32025-12-16WarningsExact identifier
application number: M020
Unseen Sunscreen Lip Protector SPF 30OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATESupergoop LLCdb12a89f-5fef-1b2a-e053-2a95a90a56f92025-12-16WarningsExact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDENatur LLC365f3c48-15a6-2d32-e063-6394a90aad782025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenZINC OXIDENatur LLC365fffa2-b846-7dd3-e063-6394a90a47cb2025-12-16Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDENatur LLC36603550-9c3d-5e33-e063-6394a90adfc92025-12-16Exact identifier
application number: M020
Shield And Protect TintedZINC OXIDETRILOGY LABORATORIES, LLC37f00e51-1123-c04c-e063-6294a90abed82025-12-16Exact identifier
application number: M020
Shield And ProtectZINC OXIDETRILOGY LABORATORIES, LLC37f09dd5-084f-3c80-e063-6394a90a7a532025-12-16Exact identifier
application number: M020
Non Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766496f-231c-f98c-e063-6294a90aae082025-12-16Exact identifier
application number: M020
Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766b0d8-20e6-a227-e063-6294a90af4da2025-12-16Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC37515807-e29a-3916-e063-6394a90a1ffd2025-12-16Exact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC374f866d-eb52-61e3-e063-6394a90a77c72025-12-16Exact identifier
application number: M020
Tinted Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC3750c23d-c3f8-fac3-e063-6394a90a135e2025-12-16Exact identifier
application number: M020
Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40ZINC OXIDEWECARE FRISCO PLLC374fe86e-cbe8-f911-e063-6294a90a96002025-12-16Exact 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