Powder

Product NDC: 61354-119
11-digit product format: 613540119
Labeler code: 61354
Product ID: 61354-119_3e142cd6-160d-62f8-e063-6394a90ae70c
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
08b8003f-40be-3380-e063-6294a90a4f6b	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
61354-119-01	Powder	100 mg in 1 CUP	POWDER	100		3
61354-119-02	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
61354-119	POWDER (TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT LLC]	2	Current NDC, 2 package rows	20250508_08b8003f-40be-3380-e063-6294a90a4f6b.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 305 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrator Plus SPF 30	BROAD SPECTRUM	CP Skin Health Group, Inc.	b6c0db82-9fba-6216-e053-2a95a90a7560	2024-02-14	Warnings	Exact identifier application number: M020
REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O	OCTINOXATE, TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	10f7ec01-541b-a15a-e063-6294a90aa9df	2024-02-09	Warnings	Exact identifier application number: M020
Sunscreen	HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Safetec of America, Inc.	754186c8-3c88-40a0-a4e3-35e3ea9d1b4c	2024-02-08	Warnings	Exact identifier application number: M020
MIAMI BEACH BUM SPF-50 Blocked Sunscreen	ZINC OXIDE	MIAMI BEACH BUM	2cf40d87-626b-4309-8f13-fd980161c62f	2024-02-07	Warnings	Exact identifier application number: M020
Equate Sunscreen for All Skin Tones SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WAL-MART INC.	1062060a-a5c7-1805-e063-6294a90ab802	2024-02-02	Warnings	Exact identifier application number: M020
Equate Kids Sunscreen Broad Spectrum SPF 50 Equate	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WAL-MART INC.	10631036-0fa6-b3ee-e063-6294a90af7aa	2024-02-02	Warnings	Exact identifier application number: M020
Death Tan SPF 50 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Derma Care Research Labs, LLC	106ab5e2-e134-b81d-e063-6294a90a5bca	2024-02-02	Warnings	Exact identifier application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden Hour	TITANIUM DIOXIDE	COOLA, LLC	edfda0f5-0f72-5cc7-e053-2a95a90ae38d	2024-02-02	Warnings	Exact identifier application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush	ZINC OXIDE	COOLA, LLC	edc6754e-dabb-5bff-e053-2a95a90a7390	2024-02-02	Warnings	Exact identifier application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Skinny Dip	ZINC OXIDE	COOLA, LLC	ee01f936-81a9-a54d-e053-2a95a90a5227	2024-02-02	Warnings	Exact identifier application number: M020
toty Solaria Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Chipican LLC	e9d590d8-e71a-0715-e053-2a95a90a5acf	2024-02-01	Warnings	Exact identifier application number: M020
THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50	ZINC OXIDE	LG H&H Co., Ltd.	10d343c8-f0c1-6b90-e063-6294a90a24ba	2024-02-01	Warnings	Exact identifier application number: M020
THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50	ZINC OXIDE	fmg Co.Ltd	10d401af-fd92-d82a-e063-6294a90a9f7f	2024-02-01	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	18f05adb-43a8-47e5-bc5a-fbf3209d0a44	2024-01-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	03593e3c-c98a-43af-82bc-10331e23342c	2024-01-31	Warnings	Exact identifier application number: M020
ATOMY SUN	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	ATOMY CO., LTD.	bdf0a11d-3563-4b09-a430-f031709cb3f3	2024-01-30	Warnings	Exact identifier application number: M020
ATOMY DERMA CALMING SUN	TITANIUM DIOXIDE	ATOMY CO., LTD.	fd5fc3ba-6e7c-4e48-8e65-47c03141df45	2024-01-30	Warnings	Exact identifier application number: M020
EltaMD UV Lip Balm SPF31	ZINC OXIDE AND OCTINOXATE SUNSCREEN	CP Skin Health, Inc	0ec70f0a-cda4-4953-b056-e1e6e9921e5b	2024-01-25	Warnings	Exact identifier application number: M020
BBW SPF 35 Natural Lip Balm	BBW SPF 35 NATURAL LIP BALM	Autumn Harp	0f8b024c-c481-951b-e063-6394a90ac63c	2024-01-22	Warnings	Exact identifier application number: M020
Bath and Body Works SPF 35 Natural Lip Balm	BATH AND BODY WORKS SPF 35 NATURAL LIP BALM	Bath and Body Works, Inc.	0f8dab80-c84f-ffbd-e063-6294a90a317e	2024-01-22	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
61354-119-01	61354011901	100 mg in 1 CUP	100 mg				Historical
61354-119-02	61354011902	1 CUP in 1 CARTON (61354-119-02) / 100 mg in 1 CUP (61354-119-01)	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