FDA.reportPublic FDA data

SUNSCREEN

Product NDC
11822-0922
Requested package NDC
11822-0922-2
11-digit product format
118220922
Labeler code
11822
Product ID
11822-0922_24546b94-3c70-4ff1-93ef-3f8be747b025
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalat, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Rite Aid
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-11-30
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30 mg/mL; mg/mL; mg/mL; mg/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-092211822-0922-2DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0922SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENE) LOTION [RITE AID]5Legacy NDC20240927_72632ff3-9d89-4a04-b1c0-4267908172bf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0922-21182209220288 mL in 1 TUBE (11822-0922-2) 88 ml2021-11-300000-00-00NoNoCurrent