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 301 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	22821e9d-eb3a-4e21-87ae-737b25125534	2024-04-03	Warnings	Exact identifier application number: M020
Meadow and Bark SPF 45 Mineral Shimmer Sunscreen	ZINC OXIDE	Meadow and Bark	14bbd191-ef3b-628e-e063-6294a90a1e66	2024-04-03	Warnings	Exact identifier application number: M020
Meadow and Bark SPF 45 Mineral Sport Sunscreen	ZINC OXIDE	Meadow and Bark	1494c0e1-97f5-411c-e063-6294a90ab2ca	2024-04-03	Warnings	Exact identifier application number: M020
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F	OCTINOXATE, ZINC OXIDE	BEL STAR S A	ea3a0e07-a277-48c8-e053-2a95a90a172f	2024-04-02	Warnings	Exact identifier application number: M020
Rio Radiance SPF 50 BodySpray	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Sol de Janeiro USA, Inc	1520a151-70c4-8699-e063-6294a90adc6b	2024-04-02	Warnings	Exact identifier application number: M020
Meijer SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	075efd92-1632-d8c8-e063-6294a90a8c1a	2024-04-02	Warnings	Exact identifier application number: M020
Good Molecules Sheer Mineral Sunscreen SPF 30	ZINC OXIDE	Good Molecules, LLC	e9596344-a7ab-f582-e053-2a95a90a5525	2024-04-02	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	f5c4186e-f167-40fc-b308-0b4406d3ec55	2024-04-02	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis Holiday	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Carma Laboratories, Inc.	95d9a485-7418-437a-8e7d-ebcc09088356	2024-04-02	Warnings	Exact identifier application number: M020
Rejuvenating Priming Moisturizer BS Sunscreen SPF30	ZINC OXIDE	Allure Labs	14cff1a3-89b9-f4da-e063-6394a90a1a41	2024-03-29	Warnings	Exact identifier application number: M020
Lemongrass Spa Products SPF 45 Tinted Mineral Sunscreen	ZINC OXIDE	Lemongrass Spa Products, LLC	14bcbaf9-76a5-f8ba-e063-6294a90a91f6	2024-03-28	Warnings	Exact identifier application number: M020
Rubber Ducky SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Carefree Skincare Ventures, LLC	14bd5cf9-423e-53a8-e063-6394a90a29f1	2024-03-28	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	132aab60-da19-7079-e063-6394a90a1d76	2024-03-27	Warnings	Exact identifier application number: M020
NAELI TINT Tinted Mineral Moisturizer SPF 50	ZINC OXIDE	ALLI LLC	25a88843-078b-4589-b8b7-ea439ba6a15b	2024-03-27	Warnings	Exact identifier application number: M020
Rio Radiance SPF 50 BodyLotion	ZINC OXIDE	SOL DE JANEIRO USA, INC.	14a85a88-c9a2-94ea-e063-6394a90a4e14	2024-03-27	Warnings	Exact identifier application number: M020
Rio Radiance SPF 50 Body Oil	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	SOL DE JANEIRO USA, INC.	14acf152-e72a-debb-e063-6294a90a243d	2024-03-27	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Amber	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0ac71c-e53a-5ff9-e063-6394a90a4807	2024-03-27	Warnings	Exact identifier application number: M020
EltaMD UV Pure SPF47	ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc.	9afe900b-4186-4189-a871-ad6f26fc26e4	2024-03-27	Warnings	Exact identifier application number: M020
Eminence Daily Defense Tinted SPF	ZINC OXIDE	Eminence Organic Skin Care	14854bad-317e-154d-e063-6294a90a884f	2024-03-25	Warnings	Exact identifier application number: M020
SPF 50 Mineral Based Facial Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Hutton, Kathleen MD	5cf0d2e3-d496-424c-ac75-70ff5b87e9ca	2024-03-25	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