SHISEIDO SUN PROTECTION LIP TREATMENT

Product NDC
52686-642
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52686-642IInactivated by FDA2026-10-15
excluded packagepackage52686-64252686-642-20IInactivated by FDA2026-10-15

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52686-642-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52686-642-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52686-642-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52686-642-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52686-642-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52686-642-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52686-642-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52686-642-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52686-642-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52686-642-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52686-642-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52686-642-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52686-642-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52686-642-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52686-642-201332a3947898…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
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-642-202024-01-30C16284748780-11030e365-466a-111a-e063-dadaa90a10e2SHISEIDO SUN PROTECTION LIP TREATMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52686-642-20SHISEIDO SUN PROTECTION LIP TREATMENT1 in 1 CARTONLIPSTICK12
52686-642-20SHISEIDO SUN PROTECTION LIP TREATMENT4 g in 1 CARTRIDGELIPSTICK42

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
DIISOSTEARYL MALATEINACTIVE INGREDIENTQBS8A3XZGQSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
GLUTATHIONEINACTIVE INGREDIENTGAN16C9B8OSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
HYDROGENATED POLYBUTENE (1300 MW)INACTIVE INGREDIENT7D1YQ9Y5EZSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
PEG/PPG-36/41 DIMETHYL ETHERINACTIVE INGREDIENTGZ406N3R9FSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
STEARYL GLYCYRRHETINATEINACTIVE INGREDIENT3YYE6VJS0PSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
THIOTAURINEINACTIVE INGREDIENTNQZ2D7AO62SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
TRIETHYLHEXANOININACTIVE INGREDIENT7K3W1BIU6KSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
TRIISOSTEARININACTIVE INGREDIENT71503RH8KGSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1
ZINC MYRISTATEINACTIVE INGREDIENTK09A9E2GGOSHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52686-642SHISEIDO SUN PROTECTION LIP TREATMENT (OCTINOXATE AND TITANIUM DIOXIDE) LIPSTICK [SHISEIDO AMERICA INC.]2Legacy NDC, 2 package rows20181214_ba1e618b-589f-4151-9e84-716a50ec8c2a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52686-642-20526860642201 CARTRIDGE in 1 CARTON (52686-642-20) > 4 g in 1 CARTRIDGE1 cartridge2012-10-010000-00-00NoNoCurrent