Skin Active

Product NDC: 49203-710
11-digit product format: 492030710
Labeler code: 49203
Product ID: 49203-710_057276ba-97a1-4870-ad23-414c873c0fbf
Type: HUMAN OTC DRUG
Nonproprietary name: Octocrylene, Avobenzone, Oxybenzone, and Ensulizole
Dosage form: CREAM
Route: TOPICAL
Labeler: Cat Media Pty Ltd
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-07-01
Marketing end: 0000-00-00
Substance: OCTOCRYLENE; AVOBENZONE; OXYBENZONE; ENSULIZOLE
Active strength: 50 mg/mL; mg/mL; mg/mL; mg/mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49203-710		I	Inactivated by FDA	2026-10-12
excluded package	package	49203-710	49203-710-01	I	Inactivated by FDA	2026-10-12
excluded package	package	49203-710	49203-710-02	I	Inactivated by FDA	2026-10-12

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 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	49203-710-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49203-710-01	`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	49203-710-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49203-710-01	`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	49203-710-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49203-710-01	`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	49203-710-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49203-710-01	`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	49203-710-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49203-710-01	`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	49203-710-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49203-710-01	`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	49203-710-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49203-710-01	`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	49203-710-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49203-710-01	`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	49203-710-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49203-710-01	`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	49203-710-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49203-710-01	`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	49203-710-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49203-710-01	`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	49203-710-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49203-710-01	`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	49203-710-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49203-710-01	`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	49203-710-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49203-710-01	`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	49203-710-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49203-710-01	`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	49203-710-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49203-710-02	`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	49203-710-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	49203-710-02	`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	49203-710-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	49203-710-02	`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	49203-710-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	49203-710-02	`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	49203-710-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	49203-710-02	`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
49203-710-01	2019-11-13	C162847	48780-1	97449f38-b774-f6ea-e053-dbdaa90aa703	Skin Active 14 ™ Intensive Day Cream
49203-710-02	2019-11-13	C162847	48780-1	97449f38-b774-f6ea-e053-dbdaa90aa703	Skin Active 14 ™ Intensive Day Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49203-710-01	Skin Active Intensive Day	50 mL in 1 BOTTLE, PUMP	CREAM	50	1
49203-710-01	Skin Active Intensive Day	1 in 1 CARTON	CREAM	1	1
49203-710-02	Skin Active Intensive Day	50 mL in 1 BOTTLE, PUMP	CREAM	50	1
49203-710-02	Skin Active Intensive Day	1 in 1 CARTON	CREAM	1	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Ensulizole	ACTIVE INGREDIENT	9YQ9DI1W42	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Avobenzone	ACTIVE MOIETY	G63QQF2NOX	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Ensulizole	ACTIVE MOIETY	9YQ9DI1W42	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Alkyl (C12-15) Benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Carbomer homopolymer Type C	INACTIVE INGREDIENT	4Q93RCW27E	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Edetate Sodium	INACTIVE INGREDIENT	MP1J8420LU	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Potassium cetyl phosphate	INACTIVE INGREDIENT	03KCY6P7UT	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49203-710	SKIN ACTIVE INTENSIVE DAY (OCTOCRYLENE, AVOBENZONE, OXYBENZONE, AND ENSULIZOLE) CREAM [CAT MEDIA PTY LTD]	1	Legacy NDC, 4 package rows	20120302_128cabae-6ce5-4e07-8698-47b1e2caf365.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
9YQ9DI1W42	ENSULIZOLE	27503-81-7	ENSULIZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
49203-710-01	49203071001	50 mL in 1 BOTTLE, PUMP	50 ml	Historical
49203-710-02	49203071002	50 mL in 1 BOTTLE, PUMP	50 ml	Historical