SHISEIDO SUN PROTECTION LIP TREATMENT

Product NDC: 52686-642
Requested package NDC: 52686-642-20
11-digit product format: 526860642
Labeler code: 52686
Product ID: 52686-642_7cf21ffd-915c-27b9-e053-2991aa0a874d
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE and TITANIUM DIOXIDE
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: SHISEIDO AMERICA INC.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-10-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; TITANIUM DIOXIDE
Active strength: 296 mg/4g; mg/4g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52686-642	52686-642-20	I	Inactivated by FDA		2026-10-15

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
52686-642-20	2024-01-30	C162847	48780-1	1030e365-466a-111a-e063-dadaa90a10e2	SHISEIDO SUN PROTECTION LIP TREATMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52686-642-20	SHISEIDO SUN PROTECTION LIP TREATMENT	1 in 1 CARTON	LIPSTICK	1		2
52686-642-20	SHISEIDO SUN PROTECTION LIP TREATMENT	4 g in 1 CARTRIDGE	LIPSTICK	4		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
DIISOSTEARYL MALATE	INACTIVE INGREDIENT	QBS8A3XZGQ	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
GLUTATHIONE	INACTIVE INGREDIENT	GAN16C9B8O	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
HYDROGENATED POLYBUTENE (1300 MW)	INACTIVE INGREDIENT	7D1YQ9Y5EZ	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
PEG/PPG-36/41 DIMETHYL ETHER	INACTIVE INGREDIENT	GZ406N3R9F	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
STEARYL GLYCYRRHETINATE	INACTIVE INGREDIENT	3YYE6VJS0P	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
THIOTAURINE	INACTIVE INGREDIENT	NQZ2D7AO62	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
TRIETHYLHEXANOIN	INACTIVE INGREDIENT	7K3W1BIU6K	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
TRIISOSTEARIN	INACTIVE INGREDIENT	71503RH8KG	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1
ZINC MYRISTATE	INACTIVE INGREDIENT	K09A9E2GGO	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52686-642	SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]	2	Legacy NDC, 2 package rows	20181214_ba1e618b-589f-4151-9e84-716a50ec8c2a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52686-642-20	52686064220	1 CARTRIDGE in 1 CARTON (52686-642-20) > 4 g in 1 CARTRIDGE	1 cartridge	2012-10-01	0000-00-00	No	No	Current