Kinesys

Product NDC: 61481-3004
11-digit product format: 614813004
Labeler code: 61481
Product ID: 61481-3004_357d069b-73d6-4559-9cc8-153ad123ab16
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OCTOCRYLENE, OCTISALATE, and Avobenzone
Dosage form: SPRAY
Route: TOPICAL
Labeler: Wilc Healthcare Inc
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-06-05
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength: 8 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61481-3004		I	Inactivated by FDA	2026-10-16
excluded package	package	61481-3004	61481-3004-1	I	Inactivated by FDA	2026-10-16
excluded package	package	61481-3004	61481-3004-4	I	Inactivated by FDA	2026-10-16

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61481-3004-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61481-3004-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61481-3004-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61481-3004-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61481-3004-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61481-3004-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61481-3004-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61481-3004-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61481-3004-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61481-3004-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61481-3004-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61481-3004-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61481-3004-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61481-3004-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61481-3004-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61481-3004-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61481-3004-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61481-3004-4	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61481-3004-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61481-3004-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61481-3004-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61481-3004-4	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61481-3004-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61481-3004-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61481-3004-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61481-3004-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61481-3004-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61481-3004-4	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61481-3004-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61481-3004-4	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61481-3004-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61481-3004-4	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61481-3004-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61481-3004-4	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61481-3004-1	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61481-3004-4	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61481-3004-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61481-3004-4	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61481-3004-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61481-3004-4	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61481-3004-1	2020-01-31	C162847	48780-1	9d75b9d0-b7ca-f424-e053-dadaa90a57ce	Kinesys ® Broad Spectrum SPF 30 Girl Alcohol-Free Spray Sunscreen
61481-3004-4	2020-01-31	C162847	48780-1	9d75b9d0-b7ca-f424-e053-dadaa90a57ce	Kinesys ® Broad Spectrum SPF 30 Girl Alcohol-Free Spray Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61481-3004-1	KinesysBroad Spectrum SPF 30 Girl Alcohol-Free Sunscreen	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		2
61481-3004-4	KinesysBroad Spectrum SPF 30 Girl Alcohol-Free Sunscreen	120 mL in 1 BOTTLE, SPRAY	SPRAY	120		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
Avobenzone	ACTIVE MOIETY	G63QQF2NOX	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
DIPHENYLSILOXY PHENYL TRIMETHICONE	INACTIVE INGREDIENT	I445L28B12	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)	INACTIVE INGREDIENT	AG75W62QYU	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [KINESYS PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61481-3004	KINESYS BROAD SPECTRUM SPF 30 GIRL ALCOHOL-FREE SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [WILC HEALTHCARE INC]	2	Legacy NDC, 2 package rows	20170713_3f42f0b8-dbd0-424e-bfe6-587391716101.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
61481-3004-1	61481300401	30 mL in 1 BOTTLE, SPRAY	30 ml	Historical
61481-3004-4	61481300404	120 mL in 1 BOTTLE, SPRAY	120 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kinesys ® Broad Spectrum SPF 30 Girl Alcohol-Free Spray Sunscreen	Wilc Healthcare Inc \| Cosmaceutical Research Laboratory Inc	2017-07-12	HUMAN OTC DRUG LABEL	2