GLYTONE Mineral Sunscreen SPF 40

Product NDC
64760-720
Requested package NDC
64760-720-01
11-digit product format
647600720
Labeler code
64760
Product ID
64760-720_d399a1cb-b497-5061-e053-2995a90a6606
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide, titanium dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Pierre Fabre USA Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-02
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
2 mg/50mL; mg/50mL
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64760-72064760-720-01DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-720GLYTONE HYDRA LIPID UV MINERAL SUNSCREEN SPF 40 PLUS (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [PIERRE FABRE USA INC.]5Legacy NDC20240430_9ffa08ea-c450-80b7-e053-2a95a90a4bd6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64760-720-01647600720011 TUBE in 1 CARTON (64760-720-01) > 50 mL in 1 TUBE1 tube2020-07-020000-00-00NoNoCurrent