Home NDC 59958-201 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 59958-201 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59958-201 59958-201-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…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 Ingredient Strength TITANIUM DIOXIDE 10.2 g/100g ZINC OXIDE 3.7 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59958-201-01 Dermaroller Anhydrous SunscreenSPF 30 30 g in 1 TUBE CREAM 30 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Titanium Dioxide ACTIVE INGREDIENT 15FIX9V2JP DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 2 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 2 Titanium Dioxide ACTIVE MOIETY 15FIX9V2JP DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 2 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 2 Cyclomethicone INACTIVE INGREDIENT NMQ347994Z DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 2 Tribehenin INACTIVE INGREDIENT 8OC9U7TQZ0 DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59958-201 DERMAROLLER ANHYDROUS SUNSCREEN SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20250112_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 225 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Defense Minerals (Medium) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e2297d4-3649-a749-e063-6294a90ac284 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Light) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e22cfde-10a1-3742-e063-6394a90ac097 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CMS LAB Inc. 2e5c2add-8ed0-a990-e063-6394a90a87ea 2025-02-14 Warnings Exact identifier application number: M020 Les Duets - Shield of Helios, sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f75a5-6a3b-a129-e063-6394a90a52a0 2025-02-14 Warnings Exact identifier application number: M020 Le Mieux Naked Glow Bronzer SPF 50 SUNSCREEN YB CHEMIA LLC 46465db7-c1f0-6980-e063-6294a90a3ed8 2025-02-14 Warnings Exact identifier application number: M020 Sheer Tint Mineral SPF Serum - Light Light ZINC OXIDE Mineral Fusion brands ac6fdc35-82f8-4805-875e-2aa91aedec6f 2025-02-14 Warnings Exact identifier application number: M020 Fre Protect Me Lightweight Daily Moisturizer SPF 50 ZINC OXIDE Peer Pharm Ltd. 3989eebc-7262-4cda-84a1-ca30b638b772 2025-02-13 Warnings Exact identifier application number: M020 Fre Protect Me Lightweight Daily Moisturizer SPF 30 ZINC OXIDE Peer Pharm Ltd. 8ee9f97b-9081-4e0c-aa7a-27a31cbee17a 2025-02-13 Warnings Exact identifier application number: M020 Fre Glow Me Lightweight Tinted Moisturizer Medium Deep ZINC OXIDE Peer Pharm Ltd. 45ed56e1-46cb-46de-b11a-e814a7446e57 2025-02-13 Warnings Exact identifier application number: M020 Fre Glow Me Lightweight Tinted Moisturizer Light Medium ZINC OXIDE Peer Pharm Ltd. 6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a 2025-02-13 Warnings Exact identifier application number: M020 Neutrogena Mineral Ultra Sheer Dry Touch SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC e99311c2-ed8b-6e60-e053-2a95a90a9bc2 2025-02-13 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 525f7bae-44b8-44e4-93ea-32995eca2566 2025-02-13 Warnings Exact identifier application number: M020 DreamBeam Sunscreen Sunlit SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC 2e093b82-2a36-cc0f-e063-6394a90a4d6d 2025-02-13 Warnings Exact identifier application number: M020 DreamBeam Sunscreen SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC f93b0091-6a41-ae6e-e053-6394a90a86d7 2025-02-13 Warnings Exact identifier application number: M020 Revealer Skin-Improving Foundation SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC 2e0a0cd6-c302-2017-e063-6394a90a60b8 2025-02-13 Warnings Exact identifier application number: M020 Hi papa KIDS MINERAL FACE SUNSCREEN SUNSCREEN GUANG DONG 3 INS TECHNOLOGY Co., Ltd 2deea723-32a0-da33-e063-6294a90accdd 2025-02-12 Warnings Exact identifier application number: M020 Quick Screen Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Quick Flick PTY LTD 3788666e-7efa-43da-95f5-6218b7fcb6ea 2025-02-12 Warnings Exact identifier application number: M020 Dolce AND Gabbana Get Your Healthy Glowy Skin ZINC OXIDE Socoplan 91bf1cca-8d18-4c59-864d-4fd0619c6713 2025-02-12 Warnings Exact identifier application number: M020 Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CMS LAB Inc. 2dfd1f99-5896-1e0f-e063-6394a90aa71d 2025-02-12 Warnings Exact identifier application number: M020 Biore Aqua Rich UV OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA f9024581-dbab-b7cb-e053-6294a90a8b9a 2025-02-12 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59958-201-01 59958020101 30 g in 1 TUBE (59958-201-01) 30 g 2011-03-01 0000-00-00 No No Current