EAU THERMALE Avene Solaire UV Mineral Multi-Dense Tinted Sunscreen Fluid SPF 50 PLUS

Product NDC: 64760-725
Requested package NDC: 64760-725-01
11-digit product format: 647600725
Labeler code: 64760
Product ID: 64760-725_c28682af-b0f0-5148-e053-2995a90abc67
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Pierre Fabre USA Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-05-17
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 120 mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	64760-725	64760-725-01	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 · 1 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 package	package	64760-725	64760-725-01	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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64760-725-01	2023-04-22	C162847	48780-1	f386c64a-3e0f-0266-e053-dadaa90a7c1a	Avene Solaire UV Tinted Mineral Sunscreen SPF 50 PLUS
64760-725-01	2023-01-30	C162847	48780-1	f386c64a-3e0f-0266-e053-dadaa90a7c1a	Avene Solaire UV Tinted Mineral Sunscreen SPF 50 PLUS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64760-725	AVENE SOLAIRE UV TINTED MINERAL SUNSCREEN SPF 50 PLUS (ZINC OXIDE) LOTION [PIERRE FABRE USA INC.]	3	Legacy NDC	20240120_c28682af-b0ef-5148-e053-2995a90abc67.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64760-725-01	64760072501	1 BOTTLE in 1 CARTON (64760-725-01) > 50 mL in 1 BOTTLE	1 bottle	2021-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Avene Solaire UV Tinted Mineral Sunscreen SPF 50 PLUS	Pierre Fabre USA Inc.	2024-01-19	HUMAN OTC DRUG LABEL	3