ULTRASOL

Product NDC
59886-304
11-digit product format
598860304
Labeler code
59886
Product ID
59886-304_02d8f0fb-f916-4a68-9c13-549489df62be
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fischer Pharmaceuticals Ltd
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-06-10
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
15 g/100g; g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct59886-304IInactivated by FDA2026-10-12
excluded packagepackage59886-30459886-304-77IInactivated by FDA2026-10-12

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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77IInactivated 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 packagepackage59886-304-77EExcluded 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
59886-304-772020-01-31C16284748780-19d75b9d0-afab-f424-e053-dadaa90a57ceDr. Fischer ULTRASOL nature BABY Sunscreen Face Cream SPF50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59886-304-77ULTRASOLnature BABY Sunscreen50 g in 1 TUBECREAM502
59886-304-77ULTRASOLnature BABY Sunscreen1 in 1 BOXCREAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Titanium DioxideACTIVE MOIETY15FIX9V2JPULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Zinc OxideACTIVE MOIETYSOI2LOH54ZULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Aluminum StearateINACTIVE INGREDIENTU6XF9NP8HMULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Coconut OilINACTIVE INGREDIENTQ9L0O73W7LULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
PanthenolINACTIVE INGREDIENTWV9CM0O67ZULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3ULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2
WaterINACTIVE INGREDIENT059QF0KO0RULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59886-304ULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]2Legacy NDC, 2 package rows20100610_723e8d14-f981-4aee-a3cf-62f0c97f5e12.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59886-304-775988603047750 g in 1 TUBE50 gHistorical