FDA.reportPublic FDA data

Blue Lizard Sheer Face SPF 50 Sunscreen

Product NDC
0316-2057
Requested package NDC
0316-2057-17
11-digit product format
003162057
Labeler code
0316
Product ID
0316-2057_ce3d8528-503e-aa32-e053-2a95a90abdb4
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-05-13
Marketing end
0000-00-00
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
67 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 packagepackage0316-20570316-2057-17DDiscontinued by firm2026-11-03

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-13Blue Lizard Sheer Face Lotion SPF 50 Sunscreen
2023-02-13Blue Lizard Sheer Face Lotion SPF 50 Sunscreen
2023-02-13Blue Lizard Sheer Face Lotion SPF 50 Sunscreen
2023-01-30Blue Lizard Sheer Face Lotion SPF 50 Sunscreen
2023-01-30Blue Lizard Sheer Face Lotion SPF 50 Sunscreen
2023-01-30Blue Lizard Sheer Face Lotion SPF 50 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2057-17Blue Lizard Sheer Face SPF 50 Sunscreen48 mL in 1 TUBELOTION487
0316-2057-17Blue Lizard Sheer Face SPF 50 Sunscreen1 in 1 CARTONLOTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2057BLUE LIZARD SHEER FACE SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]5Legacy NDC, 2 package rows20231207_baed8202-21fd-3a43-e053-2a95a90ada32.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesbaed8202-21fd-3a43-e053-2a95a90ada322026-01-12WarningsExact identifier
ndc (package): 0316-2057-17
ndc (product): 0316-2057
ndc11 (package): 00316205717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2057-17003162057171 TUBE in 1 CARTON (0316-2057-17) > 48 mL in 1 TUBE1 tube2021-05-130000-00-00NoNoCurrent