FDA.reportPublic FDA data

Blue Lizard Active Sunscreen

Product NDC
0316-2071
Requested package NDC
0316-2071-10
11-digit product format
003162071
Labeler code
0316
Product ID
0316-2071_ce53d175-7bc9-789e-e053-2a95a90acac2
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-01-02
Marketing end
0000-00-00
Substance
OCTOCRYLENE; ZINC OXIDE
Active strength
42 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 packagepackage0316-20710316-2071-10DDiscontinued by firm2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0316-20710316-2071-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0316-20710316-2071-10DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0316-2071-102023-02-13Blue Lizard Active Sunscreen
0316-2071-302023-02-13Blue Lizard Active Sunscreen
0316-2071-402023-02-13Blue Lizard Active Sunscreen
0316-2071-452023-02-13Blue Lizard Active Sunscreen
0316-2071-502023-02-13Blue Lizard Active Sunscreen
0316-2071-602023-02-13Blue Lizard Active Sunscreen
0316-2071-102023-01-30Blue Lizard Active Sunscreen
0316-2071-302023-01-30Blue Lizard Active Sunscreen
0316-2071-402023-01-30Blue Lizard Active Sunscreen
0316-2071-452023-01-30Blue Lizard Active Sunscreen
0316-2071-502023-01-30Blue Lizard Active Sunscreen
0316-2071-602023-01-30Blue Lizard Active Sunscreen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2071BLUE LIZARD ACTIVE SUNSCREEN (OCTOCRYLENE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]9Legacy NDC20241127_87aadb10-2c32-31e5-e053-2a95a90abd66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2071-10003162071105 mL in 1 PACKET (0316-2071-10) 5 ml2019-01-020000-00-00YesNoCurrent