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 86 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ST MORIZ SUNCARE BODY SUNSCREEN SPF30	SUNCARE BODY SUNSCREEN SPF30	Aopline Biotechnology (Guangzhou) Co., Ltd.	48026f09-6d15-8fa6-e063-6294a90a17cb	2026-01-09	Warnings	Exact identifier application number: M020
RODAN and FIELDS ENHANCEMENTS MEDIUM	TITANIUM DIOXIDE, ZINC OXIDE	Bentley Laboratories, LLC	6aa6ad3f-2c52-4031-9e6c-7526c42de71d	2026-01-09	Warnings	Exact identifier application number: M020
FACE SPF 47 SETTING	FACE SPF 47 SETTING SPRAY	Aopline Biotechnology (Guangzhou) Co., Ltd.	47db9a54-c02f-d2ea-e063-6394a90ab973	2026-01-08	Warnings	Exact identifier application number: M020
BADABOOM SUNSCREEN	SUNSCREEN	Aopline Biotechnology (Guangzhou) Co., Ltd.	47dbf363-2892-4530-e063-6294a90abe1f	2026-01-08	Warnings	Exact identifier application number: M020
ROE WELLNESS SPF 50 MINERAL	SPF 50 MINERAL POWDER	Aopline Biotechnology (Guangzhou) Co., Ltd.	47dc8155-4abb-4bb7-e063-6294a90af1ad	2026-01-08	Warnings	Exact identifier application number: M020
ALOHA MINERAL BLOCK-BRUSH ON MINERAL	SUNSCREEN SPF50	Aopline Biotechnology (Guangzhou) Co., Ltd.	47dd07aa-71b4-5d54-e063-6394a90a4127	2026-01-08	Warnings	Exact identifier application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45	SUNSCREEN SETTING SPRAY	Aopline Biotechnology (Guangzhou) Co., Ltd.	47ddf752-cae2-313f-e063-6294a90a7e3a	2026-01-08	Warnings	Exact identifier application number: M020
St Moriz suncare face sunscreen spf50	OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATE	Aopline Biotechnology (Guangzhou) Co., Ltd.	47df072e-151f-eb30-e063-6294a90a4eeb	2026-01-08	Warnings	Exact identifier application number: M020
SUNSCREEN GLOWING	AVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATE	Aopline Biotechnology (Guangzhou) Co., Ltd.	47df0de5-012a-c896-e063-6394a90a9cef	2026-01-08	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	616d35f6-63d2-3d26-e053-2991aa0a5b44	2026-01-08	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	616d35a1-a139-1974-e053-2a91aa0a20b6	2026-01-08	Warnings	Exact identifier application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral Sunscreen	SPF 30	EVI LABS	258b7b7c-a3f2-172c-e063-6394a90aec6a	2026-01-08	Warnings	Exact identifier application number: M020
DMK Ultrascreen Mineral Sunscreen	ZINC OXIDE	Danne Montague King	3f022275-c1e5-2704-e063-6294a90a4a81	2026-01-08	Warnings	Exact identifier application number: M020
Anhydrous SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68	2026-01-08	Warnings	Exact identifier application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 Sheer	REJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEER	Atlantic Medical Products, LLC	47e5198e-7bf6-72a8-e063-6294a90a7ec5	2026-01-08	Warnings	Exact identifier application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUM	INDE WILD SUN DEFENSE GLOW DROPS	INDE WILD PRIVATE LIMITED	47e57407-2925-09ca-e063-6294a90a49ec	2026-01-08	Warnings	Exact identifier application number: M020
NIDA Invisible Fit Sunscreen	SUNSCREEN	Proso Corp	47ed3b62-45ef-b67a-e063-6294a90a317b	2026-01-08	Warnings	Exact identifier application number: M020
Organic Matters SPF 50 Sunscreen	ZINC OXIDE	Veganic SKN Limited	12f37c8d-07f0-3e75-e063-6294a90a2cdf	2026-01-08	Warnings	Exact identifier application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50	ZINC OXIDE	Veganic SKN Limited	161a7209-10d8-928c-e063-6394a90a4139	2026-01-08	Warnings	Exact identifier application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and face	ZINC OXIDE	Veganic SKN Limited	1a97169e-67be-3d25-e063-6294a90a3b88	2026-01-08	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