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 286 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bright as Day Mineral SPF50	ZINC OXIDE	Koco Life LLC	1c245a53-4098-62e6-e063-6294a90abf12	2024-09-23	Warnings	Exact identifier application number: M020
Pure Protect Mineral Sunscreen Stick SPF50	ZINC OXIDE	Koco Life LLC	22cd5999-9b9a-91a3-e063-6394a90a0da5	2024-09-23	Warnings	Exact identifier application number: M020
ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen	ZINC OXIDE	Absolutely Natural	eb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea	2024-09-23	Warnings	Exact identifier application number: M020
SUNSCREEN 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	229dabbc-9043-3c9d-e063-6394a90a5692	2024-09-21	Warnings	Exact identifier application number: M020
GLC OG Natural Tinted SPF 30 Sunscreen	ZINC OXIDE	GUD LIFE CO. LLC	25e1e8ec-e19d-45f7-b339-5d12c2b511d6	2024-09-18	Warnings	Exact identifier application number: M020
Target Up and Up Sunscreen SPF 30 SPORT Broad Spectrum	AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE	TARGET CORPORATION	bad7d56e-662e-0776-e053-2a95a90a0af0	2024-09-18	Warnings	Exact identifier application number: M020
Target Up and Up Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	b82b6d0d-616d-f041-e053-2995a90ae6a3	2024-09-18	Warnings	Exact identifier application number: M020
COOLA Dew Good Illuminating Body Melt SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA LLC	43d293f6-e13c-4ee9-89df-2a3ef0034e31	2024-09-16	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO non-tinted replenishing daily protection	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	2203ea22-d12a-99fe-e063-6394a90aca9f	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Tinted	ZINC OXIDE	Allure Labs	22042031-ac8e-1ab2-e063-6394a90a6ed4	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Tinted	ZINC OXIDE	ONESKIN INC.	2204e776-b1a1-be15-e063-6294a90af5de	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Untinted	ZINC OXIDE	Allure Labs	2205345b-5e92-37eb-e063-6294a90a6b6c	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Untinted	ZINC OXIDE	ONESKIN INC.	2205ec0e-ac3f-299f-e063-6294a90a2174	2024-09-13	Warnings	Exact identifier application number: M020
H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUS	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f4130277-ea9b-6b25-e053-2a95a90a59be	2024-09-13	Warnings	Exact identifier application number: M020
HEB SPF 50 Tattoo Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6df491d-1fa9-a4c8-e053-6394a90a3866	2024-09-13	Warnings	Exact identifier application number: M020
YOUR Day Cream Sunscreen Broad Spectrum SPF 30	OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE	Skin Ai, LLC	21cbd5ac-5307-939b-e063-6294a90ac791	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu SPF 17	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Bentley Laboratories LLC	0fd51f8d-ee67-48fd-ab98-1fedb0339462	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu Collagen SPF 15	AVOBENZONE, OCTINOXATE, OXYBENZONE	Bentley Laboratories LLC	0246b11b-f1ba-4f47-91ab-52a6554b9467	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu The Moisture Magnet SPF 15	AVOBENZONE, OCTINOXATE, OXYBENZONE	Bentley Laboratories LLC	f6d653f5-52a0-42ad-8308-b8d6f57050cc	2024-09-10	Warnings	Exact identifier application number: M020
MARIO BADESCU SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Bentley Laboratories LLC	fe485d4c-0ded-4061-ac34-77b72d535090	2024-09-10	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