Intervene Makeup SPF 15

Product NDC
67938-091
11-digit product format
679380091
Labeler code
67938
Product ID
67938-091_3d2ed268-8c53-483d-843d-04565252e06d
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate
Dosage form
CREAM
Route
TOPICAL
Labeler
Elizabeth Arden, Inc
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-12-06
Marketing end
0000-00-00
Substance
OCTINOXATE
Active strength
2 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67938-091IInactivated by FDA2026-10-15
excluded packagepackage67938-09167938-091-01IInactivated 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 · 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 packagepackage67938-091-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67938-091-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67938-091-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67938-091-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67938-091-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67938-091-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67938-091-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67938-091-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67938-091-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67938-091-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67938-091-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67938-091-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67938-091-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67938-091-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67938-091-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67938-091-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67938-091-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67938-091-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67938-091-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67938-091-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67938-091-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67938-091-01110d247fa046…a55b01930146…

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
67938-091-012019-10-29C16284748780-1960f7f55-d388-8e05-e053-dbdaa90a074aBT0091

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-091-01Intervene Makeup SPF 151 in 1 BOXCREAM14
67938-091-02Intervene Makeup SPF 1530 mL in 1 BOTTLE, PUMPCREAM304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
OCTINOXATEACTIVE MOIETY4Y5P7MUD51INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
ETHYLPARABENINACTIVE INGREDIENT14255EXE39INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
ISODODECANEINACTIVE INGREDIENTA8289P68Y2INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
LAURETH-4INACTIVE INGREDIENT6HQ855798JINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
LAURETH-7INACTIVE INGREDIENTZ95S6G8201INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
MICAINACTIVE INGREDIENTV8A1AW0880INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
NARCISSUS TAZETTA BULBINACTIVE INGREDIENTK17762966SINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1RINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51EINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971GINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
SORBITAN TRISTEARATEINACTIVE INGREDIENT6LUM696811INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
TRIFOLIUM PRATENSE FLOWERINACTIVE INGREDIENT4JS0838828INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4
WATERINACTIVE INGREDIENT059QF0KO0RINTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-091INTERVENE MAKEUP SPF 15 (OCTINOXATE) CREAM [ELIZABETH ARDEN, INC]4Legacy NDC, 2 package rows20110722_e6dafa08-f321-45ac-bc83-51fd24d613d0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67938-091-01679380091011 in 1 BOXHistorical
67938-091-026793800910230 mL in 1 BOTTLE, PUMP30 mlHistorical