SPF 16 AGE-DEFYING TREATMENT SERUM

Product NDC
55789-3104
11-digit product format
557893104
Labeler code
55789
Product ID
55789-3104_21643b35-625e-4563-a8fc-bcd97a062085
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Mineral Fusion Natural Brands
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
3 g/96g; g/96g
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 productproduct55789-3104DDiscontinued by firm2026-10-16
excluded packagepackage55789-310455789-3104-1DDiscontinued by firm2026-10-16

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55789-3104-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55789-3104-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55789-3104-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55789-3104-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55789-3104-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55789-3104-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55789-3104-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55789-3104-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55789-3104-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55789-3104-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55789-3104-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55789-3104-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55789-3104-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55789-3104-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55789-3104-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55789-3104-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55789-3104-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55789-3104-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55789-3104-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55789-3104-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55789-3104-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55789-3104-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
55789-3104-12020-01-31C16284748780-19d75b9d0-a5fd-f424-e053-dadaa90a57ceSPF 16 AGE-DEFYING TREATMENT SERUM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
.ALPHA.-LIPOIC ACIDINACTIVE INGREDIENT73Y7P0K73YSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9SPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309SPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
GINKGOINACTIVE INGREDIENT19FUJ2C58TSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62SPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
LICORICEINACTIVE INGREDIENT61ZBX54883SPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1ESPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1RSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
POMEGRANATEINACTIVE INGREDIENT56687D1Z4DSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
SESAME OILINACTIVE INGREDIENTQX10HYY4QVSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YISPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8SPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1
WATERINACTIVE INGREDIENT059QF0KO0RSPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55789-3104SPF 16 AGE-DEFYING TREATMENT SERUM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MINERAL FUSION NATURAL BRANDS]1Legacy NDC20150827_ac6e1dd4-f28e-4840-bc9f-df063865ddc3.zip