CLE DE PEAU BEAUTE HAND

Product NDC: 58411-236
11-digit product format: 584110236
Labeler code: 58411
Product ID: 58411-236_7cf0eda6-d32d-0a25-e053-2991aa0ad38a
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE, OCTINOXATE, and OCTOCRYLENE
Dosage form: CREAM
Route: TOPICAL
Labeler: SHISEIDO AMERICAS CORPORATION
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-11-01
Marketing end: 0000-00-00
Substance: AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength: 1191 mg/75mL; mg/75mL; mg/75mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	58411-236		D	Discontinued by firm		2026-10-12
excluded package	package	58411-236	58411-236-60	D	Discontinued by firm		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 1 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58411-236-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58411-236-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58411-236-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58411-236-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58411-236-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58411-236-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58411-236-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58411-236-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58411-236-60	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58411-236-60	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58411-236-60	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58411-236-60	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58411-236-60	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58411-236-60	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58411-236-60	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58411-236-60	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58411-236-60	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58411-236-60	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
58411-236-60	2023-12-20	C162847	48780-1	9d75b9d1-1c2c-f424-e053-dadaa90a57ce	CLÉ DE PEAU BEAUTÉ HAND CREAM
58411-236-60	2020-01-31	C162847	48780-1	9d75b9d1-1c2c-f424-e053-dadaa90a57ce	CLÉ DE PEAU BEAUTÉ HAND CREAM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
2-O-ETHYL ASCORBIC ACID	INACTIVE INGREDIENT	801M14RK9K	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
BEHENETH-20	INACTIVE INGREDIENT	BJ4GP2IFLN	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
BUPLEURUM FALCATUM ROOT	INACTIVE INGREDIENT	X04E310LUY	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
CAMELLIA JAPONICA SEED OIL	INACTIVE INGREDIENT	U37N0S910T	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
EDETATE TRISODIUM	INACTIVE INGREDIENT	420IP921MB	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
HORSE CHESTNUT	INACTIVE INGREDIENT	3C18L6RJAZ	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
ISOHEXADECANE	INACTIVE INGREDIENT	918X1OUF1E	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
MYRISTYL MYRISTATE	INACTIVE INGREDIENT	4042ZC00DY	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
OLEA EUROPAEA LEAF	INACTIVE INGREDIENT	MJ95C3OH47	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
PAEONIA SUFFRUTICOSA ROOT	INACTIVE INGREDIENT	7M7E9A2C8J	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
PEG/PPG-14/7 DIMETHYL ETHER	INACTIVE INGREDIENT	6DNW9T7YT2	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
POTASSIUM METHOXYSALICYLATE	INACTIVE INGREDIENT	5G3H7U4Y7F	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
PRUNUS SPECIOSA LEAF	INACTIVE INGREDIENT	Q71D900FVU	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
ROSA DAMASCENA FLOWER OIL	INACTIVE INGREDIENT	18920M3T13	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
SODIUM ACETYLATED HYALURONATE	INACTIVE INGREDIENT	WN66R7GL93	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
SODIUM POLYMETAPHOSPHATE	INACTIVE INGREDIENT	P1BM4ZH95L	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
TREHALOSE	INACTIVE INGREDIENT	B8WCK70T7I	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
TRIISOSTEARIN	INACTIVE INGREDIENT	71503RH8KG	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLE DE PEAU BEAUTE HAND (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION]	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLÉ DE PEAU BEAUTÉ HAND CREAM	SHISEIDO AMERICAS CORPORATION \| SHISEIDO AMERICA INC.	2018-12-13	HUMAN OTC DRUG LABEL	2

CLE DE PEAU BEAUTE HAND

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#