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 222 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110OCTINOXATESHISEIDO AMERICAS CORPORATION393ce1fa-f188-45d0-a23e-2818de9749952025-03-13WarningsExact identifier
application number: M020
SHISEIDO FUTURE solution LX TOTAL PROTECTIVE SAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION1a304bf0-dcda-4887-9738-54ce35ca503b2025-03-13WarningsExact identifier
application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW PRIMERAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION805fd75e-3c53-4ddd-afdc-a65f921822d42025-03-13WarningsExact identifier
application number: M020
Visor Clear Body Oil-Free Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLC10abc330-7d45-4049-b80a-dbf58374187e2025-03-12WarningsExact identifier
application number: M020
Visor Clear Face Oil-Free Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLC462acd16-b9c0-4f02-b297-d9b54036b5312025-03-12WarningsExact identifier
application number: M020
HAWAIIAN TROPICHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEEdgewell Personal Care Brands LLC302982a3-e3f9-ef46-e063-6394a90abaf82025-03-12WarningsExact identifier
application number: M020
Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC41ff1a98-69ff-4d7a-bc89-d986a803cee32025-03-10WarningsExact identifier
application number: M020
Sheer Mineral Antioxidant Sunscreen SPF50ZINC OXIDETopiderm, Inc.1af53e89-debe-4f4c-b0ef-eec2073228df2025-03-07WarningsExact identifier
application number: M020
COOLA Firming Face Serum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLC85fd7ef4-ed08-4a69-8293-5f3f3d264c042025-03-06WarningsExact identifier
application number: M020
GOLDEN HOUR HYDRATING SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.090b5861-20f5-43c6-aff6-d17d61e8568e2025-03-04WarningsExact identifier
application number: M020
Aveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50ZINC OXIDEKenvue Brands LLCbbd6710f-a665-437e-b86b-437f732984d12025-03-04WarningsExact identifier
application number: M020
LBEL DIVINE DOUBLE USE LONGWEAR 36H SPF 15 CREME 110OCTINOXATE, ZINC OXIDEBELSTAR S.A.2f8607c5-b5ab-ed81-e063-6394a90a34532025-03-04WarningsExact identifier
application number: M020
ADVANCED PROTECTION SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f8bbd08-d199-03bd-e063-6294a90adfac2025-03-04WarningsExact identifier
application number: M020
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
application number: M020
LBEL LUMI-AGE ANTI-AGING HYDRATING DAY FACIAL SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR S.A.2f717492-347d-5bf8-e063-6294a90a4b5f2025-03-03WarningsExact identifier
application number: M020
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
application number: M020
Sum 37 Micro Active Daily Moisture SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2eea94e1-2409-8ad6-e063-6294a90a5df82025-03-03WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e23d463-fbc1-5718-e063-6294a90a72722025-03-01WarningsExact 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