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 65 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanning Club Mineral Sunscreen SPF 30ZINC OXIDETanning Club LLCd674ccbc-7bae-435c-a531-a79e569e69a92026-02-04WarningsExact identifier
application number: M020
Derma B Everyday Fit Sunscreen SPF 50AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeoPharm Co., Ltd.ba38a43d-7a8a-4814-ba34-0e99124f5fca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION42adc51f-f500-485d-82a0-1266721412622026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION60e55ebb-47b8-465e-819a-af195952e1ca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE NUTRIPERFECT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf644c67b-3a71-411b-b321-39a8b18af0c72026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation4b242b76-8aed-4939-9906-741828acd8152026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationefcf240f-95cb-45e0-b58a-9c8f3609aa552026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation270ecc83-4262-4102-a753-2acaf11360a02026-02-04WarningsExact identifier
application number: M020
Walgreens 50 Caramel and Pistachio Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4a038017-9f15-b4b2-e063-6294a90a1b232026-02-04WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationce6a28c1-56e6-4105-bc9d-9d1986ead4202026-02-04WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd52e2c61-edbc-4c26-b1a7-e8eb656db1882026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd365ed6d-a92f-473b-be19-b8b63d17f3b72026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETER0a3b4597-06fe-4689-9751-6577867d755e2026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERb83ea476-fa32-4405-9ae3-f294836edb622026-02-04WarningsExact identifier
application number: M020
Sunplus SPF50 Face Body SunscreenSUNSCREENI.Shay Cosmetics26d55baf-66dc-b1b8-e063-6394a90a670d2026-02-04WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel GlowZINC OXIDE SUNSCREENBentley Laboratories, LLC351217c4-8d71-41d9-ab08-c43857c0510c2026-02-04WarningsExact identifier
application number: M020
NIDA Invisible Fit Sun StickSUN STICKProso Corp49eca4f2-aae3-a0d5-e063-6394a90ab25f2026-02-03WarningsExact identifier
application number: M020
Shiny Hiny SPF 45 Mineral SunscreenZINC OXIDEShiny Hiny Products, LLC31adde36-5e1b-40ff-e063-6294a90a6f2e2026-02-03WarningsExact identifier
application number: M020
Walgreens 50 Passion Fruit Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49f030d8-959c-a3cd-e063-6294a90ae1ba2026-02-03WarningsExact 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