FDA.reportPublic FDA data

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPDERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZDERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2
Titanium DioxideACTIVE MOIETY15FIX9V2JPDERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2
Zinc OxideACTIVE MOIETYSOI2LOH54ZDERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2
CyclomethiconeINACTIVE INGREDIENTNMQ347994ZDERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2
TribeheninINACTIVE INGREDIENT8OC9U7TQZ0DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2

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 94 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Sensitive Mineral Face Sunscreen SPF 35ZINC OXIDE 24%Beiersdorf Incf3a8bb6b-f051-5d39-e053-2a95a90adafc2025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incf41e09bf-407d-65a4-e053-2a95a90a24362025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdort Incb5f7cacb-92b9-a6b7-e053-2a95a90aea022025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd6112fe-89e4-a79b-e053-2a95a90ad7f42025-12-31WarningsExact identifier
application number: M020
Eucerin Age Defense SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdort Inccd9d4f30-fb37-9935-e053-2995a90a99362025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Inccc5d1f9b-2c8a-1392-e053-2a95a90acb9e2025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Brightening Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e368db-4b2f-d23b-e063-6394a90a1f062025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Ultra-Light Face Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc25d9c520-431a-5546-e063-6394a90a4e0d2025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Sunscreen SPF 30(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Inc1273012a-107c-1b19-e063-6394a90a53e42025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Face Hydrating Clear Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e5bf2c-88c2-d346-e063-6394a90abc782025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Invisible Clear Sunscreen Stick SPF 55AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb728a-8c11-d041-e063-6294a90abb552025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incc0421c97-72bd-fcac-e053-2995a90aac282025-12-31WarningsExact identifier
application number: M020
Coppertone Defend and ClearOCTINOXATE, OCTISALATE, ZINC OXIDEBeiersdorf Incbaaec6a9-2c60-2d11-e053-2a95a90abca72025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incb6492438-5dd2-030e-e053-2a95a90a2f9f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdort Incca8d2e20-c1f1-ecf2-e053-2a95a90a790f2025-12-31WarningsExact identifier
application number: M020
Eucerin Tinted Age Defense Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc125d053c-9418-5772-e063-6294a90a6d6d2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport SPF 15 SunscreenAVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc4812da-0686-7789-e053-2995a90a561f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb6861830-fdad-3829-e053-2a95a90a09712025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Tear Free Mineral Sunscreen SPF 50OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 14.5%Beiersdorf Incc054fd86-b0d9-24fc-e053-2a95a90aea2c2025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc0552256-d8cb-5473-e053-2995a90ad0d52025-12-31WarningsExact 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