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 248 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b1f8bc-8b2b-451a-e063-6294a90a34bd	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b26dd0-44cb-91a7-e063-6394a90a603a	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b2b996-e02c-e40a-e063-6394a90aa0d9	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c5efde-42e1-e4fc-e063-6394a90a491d	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c5efde-42d0-e4fc-e063-6394a90a491d	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c61c42-edc9-1ebd-e063-6294a90aee13	2024-12-25	Warnings	Exact identifier application number: M020
Invisible Sunscreen SPF 40	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	COSMAX USA, CORPORATION	29fe531e-2ade-170f-e063-6394a90a1396	2024-12-24	Warnings	Exact identifier application number: M020
SOLAR MILK SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	29fe4dad-d1fb-e750-e063-6294a90ab307	2024-12-24	Warnings	Exact identifier application number: M020
CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Chantecaille Beaute Inc	d30cc344-846d-416e-ac57-4a29d4ed8263	2024-12-24	Warnings	Exact identifier application number: M020
Almay Age Smart Shade CC Luminous Primer SPF 15	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Almay, Inc.	281557c0-e668-4436-86a7-3f583091e4e4	2024-12-24	Warnings	Exact identifier application number: M020
EIGHT HOUR LIP PROTECTANT SPF 15	PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE	REVLON	2a0ac6aa-0315-d79e-e063-6294a90a9c53	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Amber	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b311f-9dcc-9b26-e063-6394a90a29a8	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Buff Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b3b8b-d38b-cd4d-e063-6294a90a919a	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Hazel	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b3b8b-d38c-cd4d-e063-6294a90a919a	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Cool Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b48b8-5953-9ab7-e063-6394a90a6b24	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Creamy Natural	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b311f-9dcd-9b26-e063-6394a90a29a8	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Rich Mahogany	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b6b99-883b-ffd4-e063-6294a90a7f4b	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light Tan	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b557a-ff60-f33f-e063-6394a90ac66f	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light Beige	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b6b99-8839-ffd4-e063-6294a90a7f4b	2024-12-24	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Light Natural	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0b668d-036e-893e-e063-6294a90a82af	2024-12-24	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