FDA.reportPublic FDA data

Blue Lizard Baby SPF 50

Product NDC
0316-2011
Requested package NDC
0316-2011-05
11-digit product format
003162011
Labeler code
0316
Product ID
0316-2011_48349da1-9d18-c24c-e063-6294a90a06a0
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Crown Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-25
Substance
ZINC OXIDE
Active strength
20 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Blue Lizard Baby SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9948f5b8-43bd-1c99-e053-2a95a90a6121Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-2011-052023-02-13C16284748780-1f386c649-af61-0266-e053-dadaa90a7c1aBlue Lizard Baby SPF 50 Sunscreen Stick
0316-2011-052023-01-30C16284748780-1f386c649-af61-0266-e053-dadaa90a7c1aBlue Lizard Baby SPF 50 Sunscreen Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2011-05Blue Lizard Baby SPF 501 in 1 BLISTER PACKSTICK18
0316-2011-05Blue Lizard Baby SPF 5014 g in 1 CYLINDERSTICK148

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2011BLUE LIZARD BABY SPF 50 (ZINC OXIDE) STICK [CROWN LABORATORIES]7Current NDC, Legacy NDC, 2 package rows20250519_9948f5b8-43bd-1c99-e053-2a95a90a6121.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 60 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
application number: M020
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
application number: M020
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
application number: M020
Reunited Lipgloss SPF 30 - BTCH IS BACKHOMOSALATE, OCTOCRYLENE, OCTISALATEPrinceville Productions, LLC, DBA Reunited Beauty4b961531-fbca-d1cf-e063-6294a90ab9a12026-02-24WarningsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer, Inc.8f5e634c-765b-4ffe-bb12-753d64c90cf92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.e97bf30a-1465-4912-bd55-1e7dd993132b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.67efcd94-00af-477b-bd14-d1c7b95d305a2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f3d2e1e-1e95-4719-8ca9-83b6b804ab9f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen Mist SPF 100AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f642788c-3643-459a-b736-0c06d0cd32a92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.95ba2b33-f593-4e95-bd6e-5910d6aa51582026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3b85004a-8832-4eac-bd70-1e607ae7af4b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.7f0fc23b-2d70-4426-9d64-a6d2b643309f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.0ae9edd8-bf76-4bb2-ab78-c43c017ba4a52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avbenzone, Homosalate, OctisalateAVBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f8960995-66b6-4197-8976-b318fe01488f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.c76f5639-bd0f-4987-8c70-224ee33bbbad2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.8795b9a7-1938-4dd9-92ad-3c044feae1da2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f8bad95-8071-47b1-88a7-3a3f09f097b52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
UV RESTORE FACE SERUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEBETTER INNOVATION LTD4b9a881a-835b-ef0c-e063-6394a90a94af2026-02-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2011-05003162011051 CYLINDER in 1 BLISTER PACK (0316-2011-05) / 14 g in 1 CYLINDER1 cylinder2019-11-250000-00-00NoNoCurrent