Powder

Product NDC: 61354-117
11-digit product format: 613540117
Labeler code: 61354
Product ID: 61354-117_3e1409fc-06d1-b3a9-e063-6294a90a06e3
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide
Dosage form: POWDER
Route: TOPICAL
Labeler: Oxygen Development LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-27
Substance: FERRIC OXIDE RED; TITANIUM DIOXIDE
Active strength: 1.75; 10 mg/100mg; mg/100mg
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Powder
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC OXIDE RED	1.75 mg/100mg
TITANIUM DIOXIDE	10 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1K09F3G675	Internal UNII lookup
15FIX9V2JP	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
08b52f29-c1a0-c673-e063-6294a90a9a7a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61354-117-01	Powder	100 mg in 1 CUP	POWDER	100		3
61354-117-02	Powder	1 in 1 CARTON	POWDER	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-117	POWDER (TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT LLC]	2	Current NDC, 2 package rows	20250508_08b52f29-c1a0-c673-e063-6294a90a9a7a.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 251 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oars and Alps SPF 50 Mineral	ZINC OXIDE	Oars and Alps LLC	f395bc39-daa5-53b8-e053-2995a90a5f48	2024-12-20	Warnings	Exact identifier application number: M020
Babyganics Kids Sheer Blend SPF50 Mineral Sunscreen	ZINC OXIDE	KAS Direct LLC dba BabyGanics	8a143645-3b52-4797-9b26-dc9dd63be38f	2024-12-20	Warnings	Exact identifier application number: M020
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Small World Brands	b1df4c81-333b-450d-963e-6670ab9bbda9	2024-12-20	Warnings	Exact identifier application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beige	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc.	062fa0d9-f384-48af-8269-42de3a788db1	2024-12-20	Warnings	Exact identifier application number: M020
Stokoderm Sunscreen PURE	AVOBENZONE, OCTOCRYLENE, OCTISALATE, AND HOMOSALATE	SC Johnson Professional USA, Inc.	3ddf81e6-de78-4f2f-814b-c75eadcddb39	2024-12-20	Warnings	Exact identifier application number: M020
BabyGanics Sunscreen 30 SPF	ZINC OXIDE, OCTINOXATE, AND OCTISALATE	KAS Direct LLC dba BabyGanics	391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAIN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299ac9a5-f609-d804-e063-6394a90abd05	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORY	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299ad424-16a8-66b1-e063-6394a90a0753	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299afef9-758f-74e1-e063-6294a90a8072	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b3276-7973-d33f-e063-6294a90a6ce1	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TAN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299afe24-d496-5745-e063-6394a90aa1b3	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b1f9a-34fd-cb50-e063-6394a90af925	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SAND	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b3236-3f3d-c9e8-e063-6394a90a7443	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNY	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b416d-ce02-3462-e063-6294a90a38f0	2024-12-19	Warnings	Exact identifier application number: M020
Puttisu	TITANIUM DIOXIDE, ZINC OXIDE	Jellycup, Inc.	a032331a-6724-d2cd-e053-2995a90ac15a	2024-12-19	Warnings	Exact identifier application number: M020
Dr. C. Tuna Resurface Essential Day Cream SPF 30	HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE	Farmasi US LLC	de493e30-d135-9def-e053-2995a90ae49a	2024-12-19	Warnings	Exact identifier application number: M020
toty Ilumina CC Cream 1N	TITANIUM DIOXIDE, ZINC OXIDE	Chipican LLC	e4efe14e-7d46-78c0-e053-2995a90a2364	2024-12-19	Warnings	Exact identifier application number: M020
Aruba Sun SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	d8b28ce6-e938-c6e3-e053-2a95a90acc29	2024-12-19	Warnings	Exact identifier application number: M020
DCH Pain Relief Roll-On	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	fda35d37-f36e-efc8-e053-6294a90a2bb8	2024-12-19	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 50 Kids	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	d53ff8f5-0b06-1e8b-e053-2a95a90ab924	2024-12-19	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61354-117-01	61354011701	100 mg in 1 CUP	100 mg				Historical
61354-117-02	61354011702	1 CUP in 1 CARTON (61354-117-02) / 100 mg in 1 CUP (61354-117-01)	1 cup	2023-10-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PUR 4-in-1 Pressed Mineral Makeup - LINEN MN3	Oxygen Development LLC \| Oxygen Development DR Limited	2025-09-05	HUMAN OTC DRUG LABEL	3