Dermaroller Anhydrous Sunscreen

Product NDC
59958-201
11-digit product format
599580201
Labeler code
59958
Product ID
59958-201_2b5d6b44-2357-bf46-e063-6294a90a378f
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Owen Biosciences, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
10.2; 3.7 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct59958-201UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59958-20159958-201-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Dermaroller Anhydrous Sunscreen
Brand name suffix
SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE10.2 g/100g
ZINC OXIDE3.7 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04e82f1b-c893-4795-b7a9-0523e3ec7552Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59958-201-012021-07-14C16284748780-1ba0f9c33-3cdb-a910-e053-dadaa90a0b85Dermaroller Anhydrous Sunscreen
59958-201-012021-01-29C16284748780-1ba0f9c33-3cdb-a910-e053-dadaa90a0b85Dermaroller Anhydrous Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-201-01Dermaroller Anhydrous SunscreenSPF 3030 g in 1 TUBECREAM306

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-201DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]6Current NDC, Legacy NDC, 1 package rows20250112_04e82f1b-c893-4795-b7a9-0523e3ec7552.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 27 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSICZINC OXIDEColorescienced46533c7-c92d-d161-e053-2995a90a8e4b2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield GlowZINC OXIDEColoresciencecdb5397a-c463-4b41-e053-2a95a90a9e032026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield MatteZINC OXIDEColoresciencecd879b3e-16a2-2cca-e053-2a95a90a14f82026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Body ShieldZINC OXIDEColoresciencecdb413bb-58ab-1e0f-e053-2995a90aab0f2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield FlexZINC OXIDEColoresciencecdb55347-aedd-4de6-e053-2a95a90afec72026-05-21WarningsExact identifier
application number: M020
Odacite Flex Perfecting Mineral Drops Tinted SunscreenZINC OXIDEOdacite52560b2d-ebb5-5d96-e063-6294a90a15ee2026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Face Shield BronzeZINC OXIDEColoresciencecdb577e4-5c80-7eac-e053-2a95a90a105b2026-05-21WarningsExact identifier
application number: M020
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC52564e2f-983d-89ba-e063-6394a90ab4242026-05-21WarningsExact identifier
application number: M020
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
application number: M020
Agent Natuer holi (sun) dewy tinted skin dropsZINC OXIDEAgent Natuer043734b8-9aee-cdf1-e063-6294a90aec602026-05-21WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty09bb5f97-f4db-a2d4-e063-6394a90a84fd2026-05-21WarningsExact identifier
application number: M020
Skin Metal Green StealthZINC OXIDESkin Metal47f562cc-48cc-97f9-e063-6294a90a72162026-05-21WarningsExact identifier
application number: M020
Blume Sunburst SunscreenZINC OXIDEBlume21ef2c6b-8ae7-8bcf-e063-6294a90ae9e12026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST13 KAMARI)ZINC OXIDEIlia, Inc.b595ca2c-177e-b357-e053-2995a90a54f62026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST6 ORA)ZINC OXIDEIlia, Inc.b59537d4-e1d8-53e4-e053-2995a90a2ce32026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST16 PAVONES)ZINC OXIDEIlia, Inc.b595f1e9-36f7-615d-e053-2a95a90abb1c2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST2.5 SOMBRIO)ZINC OXIDEIlia, Inc.b97dc2ac-dd6d-403d-e053-2995a90a0d9c2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST14 DOMINICA)ZINC OXIDEIlia, Inc.b595db16-7969-726f-e053-2995a90ab7832026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST11 MATIRA)ZINC OXIDEIlia, Inc.b595b5f0-dd3d-79ef-e053-2a95a90ad9fb2026-05-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59958-201-015995802010130 g in 1 TUBE (59958-201-01) 30 g2011-03-010000-00-00NoNoCurrent