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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04e82f1b-c893-4795-b7a9-0523e3ec7552	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59958-201-01	2021-07-14	C162847	48780-1	ba0f9c33-3cdb-a910-e053-dadaa90a0b85	Dermaroller Anhydrous Sunscreen
59958-201-01	2021-01-29	C162847	48780-1	ba0f9c33-3cdb-a910-e053-dadaa90a0b85	Dermaroller Anhydrous Sunscreen

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
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 64 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	232ab407-1903-45d8-a2b2-6992ffd30d00	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	0ccef180-0eb1-cf2b-e063-6394a90adf0c	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen for Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	6a455f1a-4285-44c3-820a-85a50d1bbc5b	2026-02-06	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	15bf22f5-a8f5-44bb-b787-2b762b330d61	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	6d1ad14e-afc6-4676-87d7-3e50e3a02fe9	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen for Babies SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	64766ed9-bd47-498d-bf59-fb30a7bf7e89	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Broad Spectrum Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	ccb651f6-e567-4c5f-9109-8767270cc4be	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	80dcd255-3a6c-4b79-b081-519c9dac990a	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Moisturizing Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Service, LLC	9de8b6b1-024b-4b71-96e6-fea68088d3ab	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	SUNSCREEN	Retail Business Services, LLC	96221c10-ebfe-4385-b6b5-d504258df36c	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Moisturizing Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	e2adbde9-3c8b-45f3-b4ef-4936b88d812d	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Sunkissed Glow	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	bf1a237b-b27e-4c55-8ded-e348240a5b9a	2026-02-06	Warnings	Exact identifier application number: M020
SEYTU Body Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Omnilife USA, Inc.	c411e9a6-b2ea-446b-a886-b92c61736e6c	2026-02-05	Warnings	Exact identifier application number: M020
SEYTU Facial Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Omnilife USA, Inc.	96fd37fb-c3ff-413f-b2c8-50754f320ecc	2026-02-05	Warnings	Exact identifier application number: M020
Sun Veil IlluminatingElixir Face Sunscreen SPF 38	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Koco Life LLC	4a15c479-d676-9e52-e063-6394a90a4eb4	2026-02-05	Warnings	Exact identifier application number: M020
Golden Sunglaze Sheer Body Mist Sunscreen SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Koco Life LLC	22d0a5db-6af1-a3ca-e063-6394a90a68ef	2026-02-05	Warnings	Exact identifier application number: M020
Sunglaze Sheer Setting Mist Sunscreen SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTYOCRYLENE	Koco Life LLC	22ce9b26-2bf8-c1ea-e063-6394a90a8ec2	2026-02-05	Warnings	Exact identifier application number: M020
Peppermint SPF 15 Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Naples Soap Company, Inc.	24adffd4-5177-f5d5-e063-6294a90a7850	2026-02-05	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Bamboo	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	ebfe03e7-614f-44b1-b1f1-78edc7e274cc	2026-02-05	Warnings	Exact identifier application number: M020
Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30	AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE	Flageoli Limited	66f29201-6cbe-46d0-b54c-005a1ecefac4	2026-02-04	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

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