Dermaroller Anhydrous Sunscreen

Manufacturer: Owen Biosciences, Inc.
Effective date: 2025-01-10
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:51:44

Label at a glance#

ProductDermaroller Anhydrous Sunscreen SPF 30

Active ingredientTITANIUM DIOXIDE, ZINC OXIDE

Label structure9 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Titanium Dioxide 10.20% Sunscreen

Zinc Oxide 3.70% Sunscreen

OTC - PURPOSE SECTION

USES

Helps Prevent sunburn.

Higher SPF gives more sunburn protection

Provides moderate protection against sunburn.

WARNINGS SECTION

Warnings

For external use only. When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash and irritation

develops and lasts. Keep out of reach of

children. If swallowed, get medical help or

contact poison control center right away.

INDICATIONS & USAGE SECTION

Directions

Apply evenly before sun exposure and as

needed. For children under 6 months of age: ask

a doctor. Reapply as needed or after towel

drying, swimming or perspiring.

INFORMATION FOR PATIENTS SECTION

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other

harmful effects of the sun.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,

Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,

Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.

Dosage & Admiinistration

DOSAGE & ADMINISTRATION SECTION

- apply liberally 15 minutes before sun exposure

- use water resistant sunscreen if swimming or sweating

- reapply at least every 2 hours

- children under 6 months: Ask a doctor

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	2
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	2
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	2
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	2
Cyclomethicone	INACTIVE INGREDIENT	NMQ347994Z	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	2
Tribehenin	INACTIVE INGREDIENT	8OC9U7TQZ0	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Dermaroller Anhydrous Sunscreen SPF 30
Titanium Dioxide, Zinc Oxide
CYCLOMETHICONE
TRIBEHENIN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59958-201	59958-201-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CYCLOMETHICONE	NMQ347994Z	IACT
TRIBEHENIN	8OC9U7TQZ0	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 64 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, CHEWABLE / ORAL		14 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE / ORAL		11 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / BUCCAL		1 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE / ORAL		14 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER / RESPIRATORY (INHALATION)	0.04 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, CHEWABLE / ORAL		14 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED / ORAL	0.01 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / BUCCAL		1 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE / ORAL		14 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CREAM / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, COATED / ORAL	0.11 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER / RESPIRATORY (INHALATION)	0.04 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CREAM / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Cyclomethicone	CYCLOMETHICONE	NMQ347994Z	CREAM / TOPICAL	13 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED / ORAL	0.01 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, COATED / ORAL	0.11 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE / ORAL		11 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	GRANULE, FOR SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	GRANULE, FOR SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	FILM / BUCCAL	0.27 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Cyclomethicone	CYCLOMETHICONE	NMQ347994Z	CREAM / TOPICAL	13 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	FILM / BUCCAL	0.27 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 40 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermaroller Anhydrous Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	04e82f1b-c893-4795-b7a9-0523e3ec7552	2025-01-10	Warnings	Exact identifier ndc (package): 59958-201-01 ndc (product): 59958-201 ndc11 (package): 59958020101 spl id: 2b5d6b44-2357-bf46-e063-6294a90a378f spl set id: 04e82f1b-c893-4795-b7a9-0523e3ec7552

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.