FDA.reportPublic FDA data

Glytone Sunscreen SPF 40

Product NDC
64760-716
Requested package NDC
64760-716-01
11-digit product format
647600716
Labeler code
64760
Product ID
64760-716_ba750628-2517-4991-e053-2995a90a2cdf
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Pierre Fabre USA Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-03-06
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength
75 mg/mL; mg/mL; 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64760-71664760-716-01DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
64760-716-012023-04-04GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-022023-04-04GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-012023-01-30GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-022023-01-30GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-012021-02-03GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-022021-02-03GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-012021-01-29GLYTONE Sunscreen Lotion Broad Spectrum SPF 40
64760-716-022021-01-29GLYTONE Sunscreen Lotion Broad Spectrum SPF 40

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64760-716-01647600716011 TUBE in 1 CARTON (64760-716-01) > 120 mL in 1 TUBE1 tube2018-03-060000-00-00NoNoCurrent