Titanium Dioxide

Product NDC: 66888-347
11-digit product format: 668880347
Labeler code: 66888
Product ID: 66888-347_efe0ec6b-98ff-858f-e053-2a95a90aec59
Type: HUMAN OTC DRUG
Nonproprietary name: Sunscreen
Dosage form: CREAM
Route: TOPICAL
Labeler: Tecnocosmesi S.p.A
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-09-24
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE
Active strength: 99 mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66888-347		D	Discontinued by firm		2026-10-05
excluded package	package	66888-347	66888-347-01	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	66888-347		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66888-347	66888-347-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66888-347	TITANIUM DIOXIDE (SUNSCREEN) CREAM [TECNOCOSMESI S.P.A]	3	Legacy NDC	20240110_cdb6ccc5-927b-473a-e053-2995a90a1624.zip

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	Marketing end	Sample	Exclude flag	Status
66888-347-01	66888034701	1 TUBE in 1 CARTON (66888-347-01) > 30 mL in 1 TUBE	1 tube	2021-09-24	0000-00-00	No	No	Current