KINESYS

Product NDC
61481-0045
11-digit product format
614810045
Labeler code
61481
Product ID
61481-0045_4816feb1-df45-4363-b815-afb59f1ae732
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
Wilc Healthcare Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-06-20
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE
Active strength
8 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61481-0045DDiscontinued by firm2026-10-20
excluded packagepackage61481-004561481-0045-1DDiscontinued by firm2026-10-20
excluded packagepackage61481-004561481-0045-2DDiscontinued by firm2026-10-20
excluded packagepackage61481-004561481-0045-3DDiscontinued by firm2026-10-20

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61481-0045-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61481-0045-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61481-0045-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61481-0045-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61481-0045-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61481-0045-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61481-0045-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61481-0045-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61481-0045-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61481-0045-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61481-0045-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61481-0045-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61481-0045-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61481-0045-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61481-0045-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61481-0045-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61481-0045-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61481-0045-3DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61481-0045-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61481-0045-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61481-0045-3DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61481-0045-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61481-0045-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61481-0045-3DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61481-0045-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61481-0045-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61481-0045-2UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51KINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WKINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YKINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPKINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51KINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WKINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YKINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPKINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
C10-30 CHOLESTEROL/LANOSTEROL ESTERSINACTIVE INGREDIENT137SL7IL0YKINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19KINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATEINACTIVE INGREDIENT832C4KF14XKINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
PPG-2 MYRISTYL ETHER PROPIONATEINACTIVE INGREDIENT88R97D8U8AKINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YKINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0KINESYS SPF 30 SOLID SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) STICK [KINESYS PHARMACEUTICAL INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61481-0045-1614810045017.3 g in 1 TUBE (61481-0045-1) 7.3 g2012-06-200000-00-00NoNoCurrent
61481-0045-2614810045024 g in 1 TUBE (61481-0045-2) 4 g2012-06-200000-00-00NoNoCurrent
61481-0045-3614810045031 TUBE in 1 PACKAGE (61481-0045-3) > 7.3 g in 1 TUBE (61481-0045-1) 1 tube2012-06-200000-00-00NoNoCurrent