STUDIO SKIN

Product NDC
10348-001
11-digit product format
103480001
Labeler code
10348
Product ID
10348-001_06fd9e72-8f61-423f-9d3b-91044b198794
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
SMASHBOX BEAUTY COSMETICS, INC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-01-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE
Active strength
5 mL/100mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10348-001IInactivated by FDA2026-08-11
excluded packagepackage10348-00110348-001-01IInactivated by FDA2026-08-11

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 · 44 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 packagepackage10348-001-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10348-001-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10348-001-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10348-001-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10348-001-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10348-001-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10348-001-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10348-001-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10348-001-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10348-001-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10348-001-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10348-001-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10348-001-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10348-001-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10348-001-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10348-001-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10348-001-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10348-001-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10348-001-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10348-001-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10348-001-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage10348-001-01110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10348-001-012019-10-29C16284748780-1960f7f55-cdfa-8e05-e053-dbdaa90a074a17a5a5a8-c1a8-4542-912b-b501f4361b53

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10348-001-01STUDIO SKIN15 HOUR WEAR FOUNDATION SPF101 in 1 CARTONLIQUID11
10348-001-02STUDIO SKIN15 HOUR WEAR FOUNDATION SPF1030 mL in 1 BOTTLELIQUID301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
MAGNESIUM SULFATE, UNSPECIFIEDINACTIVE INGREDIENTDE08037SABSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
POLYMETHYLSILSESQUIOXANE (11 MICRONS)INACTIVE INGREDIENTZ570VEV8XKSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51ESTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
TRIMETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTFZ07E4LW2MSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RSTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESTUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10348-001STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 (TITANIUM DIOXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]1Legacy NDC, 2 package rows20110630_17a5a5a8-c1a8-4542-912b-b501f4361b53.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
10348-001-01103480001011 in 1 CARTONHistorical
10348-001-021034800010230 mL in 1 BOTTLE30 mlHistorical