FDA.reportPublic FDA data

Glytone Daily Body

Product NDC
64760-713
11-digit product format
647600713
Labeler code
64760
Product ID
64760-713_ba74ef9e-6eac-0f3e-e053-2a95a90ab22a
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, octinoxate, octocrylene, oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Pierre Fabre USA Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-10-03
Marketing end
0000-00-00
Substance
OXYBENZONE; OCTOCRYLENE; OCTINOXATE; AVOBENZONE
Active strength
3 g/100mL; g/100mL; g/100mL; g/100mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64760-713DDiscontinued by firm2026-08-11
excluded packagepackage64760-71364760-713-01DDiscontinued 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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64760-713-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64760-713-01f5e01cc5f278…a2eaf40c39c3…

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-04-04Glytone Daily Body Lotion Broad Spectrum SPF 15
2023-01-30Glytone Daily Body Lotion Broad Spectrum SPF 15
2021-02-03Glytone Daily Body Lotion Broad Spectrum SPF 15
2021-01-29Glytone Daily Body Lotion Broad Spectrum SPF 15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-713GLYTONE DAILY BODY (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) LOTION [PIERRE FABRE USA INC.]5Legacy NDC20240119_91baf7df-a1fa-6739-e053-2a95a90a6e31.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64760-713-0164760071301355 mL in 1 BOTTLE, PUMP (64760-713-01) 355 ml2017-10-030000-00-00NoNoCurrent