KINeSYS EarthKind SPF 30 Sunscreen

Product NDC
61481-0037
11-digit product format
614810037
Labeler code
61481
Product ID
61481-0037_0285d3fa-c9c9-4bc8-9883-b6331066dec3
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
KINeSYS Pharmaceutical Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-02-01
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
250 g/1000g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61481-0037IInactivated by FDA2026-10-12
excluded packagepackage61481-003761481-0037-3IInactivated by FDA2026-10-12

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61481-0037-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61481-0037-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61481-0037-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61481-0037-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61481-0037-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61481-0037-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61481-0037-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61481-0037-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61481-0037-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61481-0037-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61481-0037-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61481-0037-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61481-0037-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61481-0037-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61481-0037-31332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61481-0037-3fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61481-0037-386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61481-0037-3bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61481-0037-38dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61481-0037-3e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61481-0037-39bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61481-0037-3110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61481-0037-32019-10-29C16284748780-1960f7f55-bf90-8e05-e053-dbdaa90a074a9b41d15a-b0c3-4e97-9c43-6a445b88fe94

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61481-0037-3KINeSYS EarthKind SPF 30 Sunscreen90 g in 1 JAROINTMENT908

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1KINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
GLYCERYL ISOSTEARATEINACTIVE INGREDIENTHYE7O27HAOKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM393KINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
SOYBEAN OILINACTIVE INGREDIENT241ATL177AKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
TRICAPRININACTIVE INGREDIENTO1PB8EU98MKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VKINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61481-0037KINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]8Legacy NDC, 1 package rows20110228_9b41d15a-b0c3-4e97-9c43-6a445b88fe94.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61481-0037-36148100370390 g in 1 JAR90 gHistorical