ck one3-in-1face makeup

Product NDC
66184-400
11-digit product format
661840400
Labeler code
66184
Product ID
66184-400_e71e7dfa-968d-4619-9932-4fa2b7ef6519
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Coty US LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-02-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; OCTINOXATE
Active strength
8 mL/30mL; mL/30mL
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66184-400IInactivated by FDA2026-10-21
excluded packagepackage66184-40066184-400-01IInactivated by FDA2026-10-21
excluded packagepackage66184-40066184-400-02IInactivated by FDA2026-10-21

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 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 packagepackage66184-400-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66184-400-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66184-400-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66184-400-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66184-400-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66184-400-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66184-400-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66184-400-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66184-400-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66184-400-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66184-400-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66184-400-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66184-400-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66184-400-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66184-400-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66184-400-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66184-400-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66184-400-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66184-400-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66184-400-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66184-400-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66184-400-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66184-400-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66184-400-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66184-400-028af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66184-400-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66184-400-02834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66184-400-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66184-400-021332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66184-400-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66184-400-02fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66184-400-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66184-400-0286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66184-400-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66184-400-02bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66184-400-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66184-400-028dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66184-400-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66184-400-02e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66184-400-01e2bbac7714bc…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
NDCEffectiveActionDocumentIndexing SPLRelated label
66184-400-012019-11-13C16284748780-197449f38-ba62-f6ea-e053-dbdaa90aa703Drug Facts
66184-400-022019-11-13C16284748780-197449f38-ba62-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66184-400-01ck one3-in-1face makeupwith SPF8 sunscreen30 mL in 1 CONTAINERLIQUID301
66184-400-02ck one3-in-1face makeupwith SPF8 sunscreen30 mL in 1 BOXLIQUID301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51CK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
OctinoxateACTIVE MOIETY4Y5P7MUD51CK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Alaria EsculentaINACTIVE INGREDIENTEJ9JK8J58DCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Alpha-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0CK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Aluminum DimyristateINACTIVE INGREDIENTJ2KA067N9OCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RACK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438UCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Disodium Stearoyl GlutamateINACTIVE INGREDIENT45ASM2L11MCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Hyaluronate SodiumINACTIVE INGREDIENTYSE9PPT4THCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Methyl MethacrylateINACTIVE INGREDIENT196OC77688CK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Neopentyl GlycolINACTIVE INGREDIENTQI80HXD6S5CK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0CK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Sorbic AcidINACTIVE INGREDIENTX045WJ989BCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
TocopherolINACTIVE INGREDIENTR0ZB2556P8CK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
TricaprinINACTIVE INGREDIENTO1PB8EU98MCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08ECK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVCCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RCK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66184-400CK ONE3-IN-1FACE MAKEUP WITH SPF8 SUNSCREEN (TITANIUM DIOXIDE) LIQUID [COTY US LLC]1Legacy NDC, 2 package rows20120201_9b905703-6fc9-4661-8edd-40bbdf3a3951.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66184-400-016618404000130 mL in 1 CONTAINER30 mlHistorical
66184-400-026618404000230 mL in 1 BOX30 mlHistorical