MDSOLARSCIENCES

Product NDC
49358-547
11-digit product format
493580547
Labeler code
49358
Product ID
49358-547_087d6ada-ade1-4709-9204-f85906af016f
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
MD Solar Sciences
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-01-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
15 mg/g; mg/g
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 productproduct49358-547IInactivated by FDA2026-10-05
excluded packagepackage49358-54749358-547-01IInactivated by FDA2026-10-05

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 · 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 packagepackage49358-547-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49358-547-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49358-547-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49358-547-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49358-547-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49358-547-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49358-547-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49358-547-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49358-547-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49358-547-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49358-547-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49358-547-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49358-547-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49358-547-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49358-547-011332a3947898…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
49358-547-012023-01-30C16284748780-1f386c64a-454e-0266-e053-dadaa90a7c1aMDSOLARSCIENCES™ SPF 30 Mineral Tinted Crème

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-547-01MDSOLARSCIENCES SPF 30 Mineral Tinted1 in 1 CARTONCREAM14
49358-547-01MDSOLARSCIENCES SPF 30 Mineral Tinted48 g in 1 TUBECREAM484

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
Zinc OxideACTIVE MOIETYSOI2LOH54ZMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
Butyloctyl SalicylateINACTIVE INGREDIENT2EH13UN8D3MDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
CranberryINACTIVE INGREDIENT0MVO31Q3QSMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
DimethiconeINACTIVE INGREDIENT92RU3N3Y1OMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
Glyceryl IsostearateINACTIVE INGREDIENTHYE7O27HAOMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
Green Tea LeafINACTIVE INGREDIENTW2ZU1RY8B0MDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7UMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
PEG/PPG-18/18 DimethiconeINACTIVE INGREDIENT9H0AO7T794MDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
Polysilicone-15INACTIVE INGREDIENTF8DRP5BB29MDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
Punica Granatum Root BarkINACTIVE INGREDIENTCLV24I3T1DMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
Tetrahexyldecyl AscorbateINACTIVE INGREDIENT9LBV3F07AZMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08EMDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-547MDSOLARSCIENCES SPF 30 MINERAL TINTED (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MD SOLAR SCIENCES]4Legacy NDC, 2 package rows20181018_7b139f86-d8f4-4c7e-845d-490e7b769b8e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49358-547-01493580547011 TUBE in 1 CARTON (49358-547-01) > 48 g in 1 TUBE1 tube2016-01-010000-00-00NoNoCurrent