FDA.reportPublic FDA data

Foundation

Product NDC
61354-040
Requested package NDC
61354-040-03
11-digit product format
613540040
Labeler code
61354
Product ID
61354-040_bc0737d7-de8b-32c4-e053-2995a90aa249
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate
Dosage form
EMULSION
Route
TOPICAL
Labeler
Oxygen Development LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-02-23
Marketing end
0000-00-00
Substance
OCTINOXATE
Active strength
5 mg/100mg
NDC exclude flag
No
Listing certified through
2022-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61354-04061354-040-03DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
61354-040-012025-01-30f386c649-ec91-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15
61354-040-022025-01-30f386c649-ee81-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 BLUSH MEDIUM
61354-040-032025-01-30f386c64a-07f2-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 LIGHT TAN
61354-040-042025-01-30f386c64a-0db7-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 LIGHT
61354-040-012023-02-10f386c649-ec91-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15
61354-040-022023-02-10f386c649-ee81-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 BLUSH MEDIUM
61354-040-032023-02-10f386c64a-07f2-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 LIGHT TAN
61354-040-042023-02-10f386c64a-0db7-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 LIGHT
61354-040-012023-01-30f386c649-ec91-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15
61354-040-022023-01-30f386c649-ee81-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 BLUSH MEDIUM
61354-040-032023-01-30f386c64a-07f2-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 LIGHT TAN
61354-040-042023-01-30f386c64a-0db7-0266-e053-dadaa90a7c1aPUR 4-IN-1 LIQUID 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 LIGHT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-040-01Foundation27 mg in 1 BOTTLE, GLASSEMULSION272
61354-040-01Foundation1 in 1 CARTONEMULSION12
61354-040-02Foundation1 in 1 CARTONEMULSION12
61354-040-02Foundation27 mg in 1 BOTTLE, GLASSEMULSION272
61354-040-03Foundation1 in 1 CARTONEMULSION12
61354-040-03Foundation27 mg in 1 BOTTLE, GLASSEMULSION272
61354-040-04Foundation1 in 1 CARTONEMULSION12
61354-040-04Foundation27 mg in 1 BOTTLE, GLASSEMULSION272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-040FOUNDATION (OCTINOXATE) EMULSION [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc0785c0-3f6d-3cc1-e053-2995a90aed3b.zip
61354-040FOUNDATION (OCTINOXATE) EMULSION [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc044b2b-2885-1338-e053-2995a90ac4d1.zip
61354-040FOUNDATION (OCTINOXATE) EMULSION [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc063ccb-254e-4fdc-e053-2995a90a9cac.zip
61354-040FOUNDATION (OCTINOXATE) EMULSION [OXYGEN DEVELOPMENT LLC]2Legacy NDC, 2 package rows20230211_bc074bef-b7ff-f460-e053-2a95a90a854c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61354-040-03613540040031 BOTTLE, GLASS in 1 CARTON (61354-040-03) > 27 mg in 1 BOTTLE, GLASS2021-02-230000-00-00NoNoCurrent