Powder

Product NDC: 61354-189
11-digit product format: 613540189
Labeler code: 61354
Product ID: 61354-189_4d39fb2d-8fa3-07c9-e063-6394a90a0d4e
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: 2025-07-25
Substance: TITANIUM DIOXIDE
Active strength: 10 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
TITANIUM DIOXIDE	10 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
4d39ed7a-ca80-893c-e063-6294a90a03e7	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
61354-189-01	Powder	1 in 1 CARTON	POWDER	1		1
61354-189-01	Powder	100 mg in 1 CUP	POWDER	100		1

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 105 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d3bd710b-7d1a-4f96-9fbc-a67c550d863b	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	3b6ea0ec-4636-43cf-a324-a82666108e95	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5ac7fb96-a2f2-4086-82ad-c45d7a709091	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	84a5f7e1-1c04-43cd-8d3b-60c7e2418faf	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	28a61b11-5901-47ec-916c-e2ae4f79a11d	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5ddf8221-9bfc-4c52-9a51-a0d725b7a23e	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5937248a-b96e-490a-9f93-10e65969ac10	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2cc7d9f6-f789-4f9b-91b7-73f9d0fee85c	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	62136c4c-6f05-4de0-a71e-55aa53160685	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WP	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a8037741-ec57-43e7-adb4-2a93941ee108	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WO	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6f872199-067e-40aa-bf34-549ecc33b1ac	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4f27a485-1e8b-4f34-99a8-0d0a3cf1b9db	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	938a5c4a-b9dd-4089-8b20-7030f032591d	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	1357ab72-0d73-41da-8f55-7bd6d97c9ae8	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2d63bdc5-5338-48c4-9c59-bfb9900ab920	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a315ed9c-bc19-40e9-85ab-50ac1daa5449	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3WP	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a63ea887-cbe0-4a04-ad62-4d3a87ece113	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3WO	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	15c50e40-b97d-4612-a533-cf9d1d57b417	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	63711abf-e906-4c07-bc2d-f8e10fead2f0	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 3N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	21455f0c-0190-4519-a8e3-34206d1f7a42	2025-12-19	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
61354-189-01	61354018901	1 CUP in 1 CARTON (61354-189-01) / 100 mg in 1 CUP	1 cup	2025-07-25	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	2026-03-17	HUMAN OTC DRUG LABEL	1