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 183 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZER FRAGRANCE-FREE	ZINC OXIDE	KENDO HOLDINGS INC	19120c3f-8fc0-62c3-e063-6394a90a30f3	2025-09-30	Warnings	Exact identifier application number: M020
FENTY SKIN HYDRA VIZOR SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	KENDO HOLDINGS INC	1d26bfb0-3c05-4a0c-9d4b-810359222730	2025-09-30	Warnings	Exact identifier application number: M020
FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZER	ZINC OXIDE	KENDO HOLDINGS INC	fd16def1-4c88-3ad0-e053-6294a90ab088	2025-09-30	Warnings	Exact identifier application number: M020
FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HAND	ZINC OXIDE	KENDO HOLDINGS INC	f92b75bd-c5b7-0320-e053-6394a90ab4c3	2025-09-30	Warnings	Exact identifier application number: M020
OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN SPF 30	ZINC OXIDE	KENDO HOLDINGS INC	f92ae08e-0bca-4775-e053-6394a90ab3d6	2025-09-30	Warnings	Exact identifier application number: M020
Sun Kids mineral STRAWBERRY SUNSCREEN BROAD SPECTRUM SPF 50	ZINC OXIDE	The Natural SKN Company	400c67aa-55a6-67ea-e063-6294a90a0213	2025-09-30	Warnings	Exact identifier application number: M020
toty Ilumina CC Creamy Compact Refill 1C	TITANIUM DIOXIDE	Chipican LLC	f0596830-77ed-11f0-e053-2995a90a8ff5	2025-09-29	Warnings	Exact identifier application number: M020
U V-Lamp Shield Mani-Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3fe7e1c3-e6cd-1420-e063-6394a90a4138	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	053e76f0-8ca0-645d-e063-6394a90a01d2	2025-09-28	Warnings	Exact identifier application number: M020
Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30	ZINC OXIDE	Edgewell Personal Care Brands LLC	cdc54f23-0efb-2fb4-e053-2995a90ae58b	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	0540017a-52ac-7972-e063-6394a90a139c	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	08f3b27f-b233-d406-e063-6394a90ada76	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	128a3772-b9b7-0d10-e063-6294a90a3e05	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	203c82a2-0131-8023-e063-6294a90aba7b	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	203c780a-3107-d71a-e063-6394a90aca25	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	31d01fae-4085-d84a-e063-6294a90ab981	2025-09-28	Warnings	Exact identifier application number: M020
Hawaiian Tropic	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands, LLC	3388c2fa-8082-95d4-e063-6294a90a94b8	2025-09-28	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	b10a7794-7e4f-412b-9eb2-773107ecb7fc	2025-09-26	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 50	HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%	Black Girl Sunscreen	fed22570-e0ae-43e1-b6ce-1f0ad01684c3	2025-09-26	Warnings	Exact identifier application number: M020
Smooth Even Glow	TINTED SUNSCREEN BROAD SPF30	SKNVcare, LLC	3fa48151-fcb9-3d35-e063-6394a90a2eb6	2025-09-25	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