MINERAL FOUNDATION

Product NDC
76354-103
11-digit product format
763540103
Labeler code
76354
Product ID
76354-103_5c4bf2cf-3501-40e5-85cc-4bdbf79cd625
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
POWDER
Route
TOPICAL
Labeler
J. A. Cosmetics U.S. INC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-10
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
10 g/100g; 1/100g
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 productproduct76354-103DDiscontinued by firm2026-10-05
excluded packagepackage76354-10376354-103-51DDiscontinued 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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76354-103-51DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76354-103-51DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76354-103-51DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76354-103-51DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76354-103-51DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76354-103-51DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76354-103-51DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76354-103-51DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76354-103-51DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76354-103-51DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76354-103-51DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76354-103-51DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76354-103-51IInactivated by FDA110d247fa046…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
76354-103-512019-12-24C16284748780-19855e2a2-3cdb-60a7-e053-dbdaa90a05bdd09a4d91-73c0-4fea-a595-bbfcdda08438
76354-103-512019-11-27C16284748780-19855e2a2-3cdb-60a7-e053-dbdaa90a05bdd09a4d91-73c0-4fea-a595-bbfcdda08438

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
ZINC CATIONACTIVE MOIETY13S1S8SF37MINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0MINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
BISMUTH OXYCHLORIDEINACTIVE INGREDIENT4ZR792I587MINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
BORON NITRIDEINACTIVE INGREDIENT2U4T60A6YDMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8MINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C5MINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
MICAINACTIVE INGREDIENTV8A1AW0880MINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971GMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3
ULTRAMARINE BLUEINACTIVE INGREDIENTI39WR998BIMINERAL FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [J. A. COSMETICS U.S. INC]3