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 278 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate Sunscreen SPORT SPF 100	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE	Walmart Stores Inc.	4fc58cea-082a-4535-9c51-8e7dedc15be3	2024-10-16	Warnings	Exact identifier application number: M020
Equate Sunscreen SPF 50 KIDS Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	WAL-MART STORES INC	81cb6b2e-1ca3-4a83-a8df-9bfee61e79af	2024-10-16	Warnings	Exact identifier application number: M020
Equate Sunscreen SPF100 SPORT Broad Spectrum	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE	WAL-MART STORES INC	1ce4839b-f693-4653-8fe2-444df76eb83c	2024-10-16	Warnings	Exact identifier application number: M020
Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50	HOMOSALATE , OCTOCRYLENE, ZINC OXIDE	Wal-Mart Stores Inc	0cdfc3a1-4bfa-474d-a4eb-4bfa1e628c89	2024-10-16	Warnings	Exact identifier application number: M020
EQUATE Sunscreen BABY Broad Spectrum SPF 50	AVOBENZONE HOMOSALATE OCTOCRYLENE	WAL-MART STORES INC	b2083cbd-ef19-4edc-9d7d-eca3452ee0ee	2024-10-16	Warnings	Exact identifier application number: M020
Equate-Sunscreen Broad Spectrum SPF 50 ULTRA	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	Wal-Mart Stores Inc	bbe06f23-0d0f-43ff-9d1b-37a99d9d6206	2024-10-16	Warnings	Exact identifier application number: M020
BIG LOTS SOUNDBODY SPF 50 SPORT SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BIG LOTS STORES, INC.	c8c1c904-12f5-48e0-e053-2a95a90a9f75	2024-10-16	Warnings	Exact identifier application number: M020
Big Lots Soundbody SPF 70 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	BIG LOTS STORES, INC.	e717ec77-8beb-645a-e053-2a95a90ac11b	2024-10-16	Warnings	Exact identifier application number: M020
Big Lots Soundbody SPF 50 Ultra Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	BIG LOTS STORES, INC.	f0dcb5d8-a3e5-4334-e053-2995a90a535a	2024-10-16	Warnings	Exact identifier application number: M020
Big Lots Soundbody SPF 30 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE,	BIG LOTS STORES, INC.	c8aede4f-3d84-63d1-e053-2a95a90afb1a	2024-10-16	Warnings	Exact identifier application number: M020
Big Lots Soundbody SPF 70 Sun Defense	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	BIG LOTS STORES, INC.	db3ad809-d6c9-6c83-e053-2a95a90ac58b	2024-10-16	Warnings	Exact identifier application number: M020
BIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BIG LOTS STORES, INC.	e4b70fdb-7548-175c-e053-2995a90adfe6	2024-10-16	Warnings	Exact identifier application number: M020
BIOLUMIN-C HEAT AGING PROTECTOR SPF50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	38d0b78b-bd8e-4cb0-925a-19adff550c19	2024-10-16	Warnings	Exact identifier application number: M020
Vanicream Facial Moisturizer Broad Spectrum SPF30	ZINC OXIDE	Pharmaceutical Specialties Inc	d8c9a8d0-1f24-2240-e053-2a95a90a8dee	2024-10-15	Warnings	Exact identifier application number: M020
Mula Maldives SPF 30 Moisturizing Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Mula Maldives PVT LTD	f9be092f-8d53-4bb2-8363-81c003da42d6	2024-10-15	Warnings	Exact identifier application number: M020
Kroger Invisible Sunscreen SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	THE KROGER COMPANY	f71ee1cd-e075-9ee9-e053-6394a90a8f9f	2024-10-15	Warnings	Exact identifier application number: M020
Kroger Sunscreen Oil SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	THE KROGER COMPANY	f76e12aa-9d98-5694-e053-6294a90a5256	2024-10-15	Warnings	Exact identifier application number: M020
Kroger Sport Sunscreen Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE	THE KROGER COMPANY	f0f350f4-b1b9-f4d3-e053-2995a90ac459	2024-10-15	Warnings	Exact identifier application number: M020
Kroger Shimmer Sunscreen Hydrating SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE	THE KROGER COMPANY	f76fe840-0da2-a903-e053-6294a90a05ee	2024-10-15	Warnings	Exact identifier application number: M020
MINERAL BASED SPF 50 SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	THE KROGER COMPANY	a4e6936d-a76c-e8fd-e053-2995a90a965f	2024-10-15	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