FDA.reportPublic FDA data

Aveeno Protect Plus Soothe Mineral Sunscreen Broad Spectrum SPF 50

Product NDC
69968-0780
11-digit product format
699680780
Labeler code
69968
Product ID
69968-0780_ef4c01d8-47d8-8c74-e053-2a95a90a8f57
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Johnson & Johnson Consumer Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-11-29
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
216 mg/g
NDC exclude flag
No
Listing certified through
2024-12-31
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 productproduct69968-0780DDiscontinued by firm2026-10-15
excluded packagepackage69968-078069968-0780-2DDiscontinued 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
69968-0780AVEENO PROTECT PLUS SOOTHE MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 (ZINC OXIDE) STICK [KENVUE BRANDS LLC]3Legacy NDC20241107_ea1eac5c-3251-6277-e053-2a95a90a5fba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0780-26996807800242 g in 1 CANISTER (69968-0780-2) 42 g2022-11-290000-00-00NoNoCurrent