Rosease By Anna Lotan Gentle Daytime Broad Spectrum SPF 30

Product NDC
76446-648
11-digit product format
764460648
Labeler code
76446
Product ID
76446-648_af45f6f0-b764-4d36-8d31-e3884c19eb3a
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Anna Lotan Ltd
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-05-25
Marketing end
0000-00-00
Substance
OCTINOXATE; ZINC OXIDE
Active strength
8 g/100mL; g/100mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76446-648DDiscontinued by firm2026-10-16
excluded packagepackage76446-64876446-648-75DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76446-648-75Rosease By Anna Lotan Gentle Daytime Broad Spectrum SPF 301 in 1 CARTONCREAM13
76446-648-75Rosease By Anna Lotan Gentle Daytime Broad Spectrum SPF 3075 mL in 1 BOTTLE, PUMPCREAM753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76446-648ROSEASE BY ANNA LOTAN GENTLE DAYTIME BROAD SPECTRUM SPF 30 (OCTINOXATE, ZINC OXIDE) CREAM [ANNA LOTAN LTD]2Legacy NDC, 2 package rows20241009_c9e1afe1-4b1d-42d0-a1fe-b554adeaf811.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76446-648-75764460648751 BOTTLE, PUMP in 1 CARTON (76446-648-75) > 75 mL in 1 BOTTLE, PUMP2022-05-250000-00-00NoNoCurrent