NeoStrata Sheer Physical Protection

Product NDC: 58414-0018
Requested package NDC: 58414-0018-1
11-digit product format: 584140018
Labeler code: 58414
Product ID: 58414-0018_0772fd02-023b-4f4b-995a-a808ec4674e0
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: NeoStrata Company Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2018-09-01
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 70 mg/mL; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58414-0018	58414-0018-1	D	Discontinued by firm		2026-10-20

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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58414-0018-1	2022-03-09	C162847	48780-1	9d75b9d1-013b-f424-e053-dadaa90a57ce	NeoStrata ® Sheer Physical Protection
58414-0018-1	2020-01-31	C162847	48780-1	9d75b9d1-013b-f424-e053-dadaa90a57ce	NeoStrata ® Sheer Physical Protection

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58414-0018	NEOSTRATA SHEER PHYSICAL PROTECTION SUNSCREEN BROAD SPECTRUM SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [NEOSTRATA COMPANY INC.]	4	Legacy NDC	20250112_30042428-a0d4-4259-a678-6f40d3bffe41.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58414-0018-1	58414001801	1 BOTTLE, PLASTIC in 1 CARTON (58414-0018-1) > 50 mL in 1 BOTTLE, PLASTIC	2018-09-01	0000-00-00	No	No	Current