FDA.reportPublic FDA data

Blue Lizard Sensitive SPF 50 Sunscreen

Product NDC
0316-2046
11-digit product format
003162046
Labeler code
0316
Product ID
0316-2046_474c85a7-dbae-29f6-e063-6394a90ae5f4
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-02
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
89.6; 112 mg/mL; mg/mL
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 Sensitive SPF 50 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE89.6 mg/mL
ZINC OXIDE112 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
32d78048-d281-1d80-e063-6394a90aec19Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0316-2046-102023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-102023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-102023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-302023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-302023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-302023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-402023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-402023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-402023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-452023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-452023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-452023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-502023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-502023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-502023-02-13Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-102023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-102023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-102023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-302023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-302023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-302023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-402023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-402023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-402023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-452023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-452023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-452023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-502023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-502023-01-30Blue Lizard Sensitive SPF 50 Sunscreen
0316-2046-502023-01-30Blue Lizard Sensitive SPF 50 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2046-10Blue Lizard Sensitive SPF 50 Sunscreen5 mL in 1 PACKETLOTION56
0316-2046-30Blue Lizard Sensitive SPF 50 Sunscreen89 mL in 1 TUBELOTION896
0316-2046-40Blue Lizard Sensitive SPF 50 Sunscreen148 mL in 1 BOTTLE, PLASTICLOTION1486
0316-2046-45Blue Lizard Sensitive SPF 50 Sunscreen148 mL in 1 TUBELOTION1486
0316-2046-50Blue Lizard Sensitive SPF 50 Sunscreen259 mL in 1 BOTTLE, PLASTICLOTION2596
0316-2046-31Blue Lizard Sensitive SPF 50 Sunscreen89 mL in 1 TUBELOTION893
0316-2046-46Blue Lizard Sensitive SPF 50 Sunscreen148 mL in 1 TUBELOTION1483
0316-2046-51Blue Lizard Sensitive SPF 50 Sunscreen259 mL in 1 BOTTLE, PLASTICLOTION2593
0316-2046-55Blue Lizard Sensitive SPF 50 Sunscreen5 mL in 1 PACKETLOTION53
0316-2046-82Blue Lizard Sensitive SPF 50 Sunscreen30 mL in 1 TUBELOTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-2046-30ML - Milliliter0316-2046ff3829d3-cfb3-4ac8-8cc2-9e52affdb3be12026-04-20
0316-2046-45ML - Milliliter0316-204633cd0b66-0c43-4ded-8a27-4e893d6e185412026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2046BLUE LIZARD SENSITIVE SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]4Current NDC, Legacy NDC, 5 package rows20231206_9d20b230-2cce-4d90-e053-2995a90a4c03.zip
0316-2046BLUE LIZARD SENSITIVE SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]2Current NDC, Legacy NDC, 5 package rows20250525_32d78048-d281-1d80-e063-6394a90aec19.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 122 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrating Mineral Zinc Oxide SPF 40ZINC OXIDESpalina LLC.35aa74c5-1bb3-9814-e063-6294a90a69992025-12-15Exact identifier
application number: M020
Mineral Tinted SPF40 with ceramidesZINC OXIDESpalina LLC.35ac3bd1-a4c1-5078-e063-6394a90afdc82025-12-15Exact identifier
application number: M020
Suns Out Funs OutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC46040acf-512e-c867-e063-6294a90ac2202025-12-15WarningsExact identifier
application number: M020
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3981c878-826d-f685-e063-6294a90acb242025-12-15Exact identifier
application number: M020
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984c4b7-94ee-2a8e-e063-6294a90ac24f2025-12-15Exact identifier
application number: M020
Ultra Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc833d-f231-5f52-e063-6394a90a37a62025-12-15Exact identifier
application number: M020
Ultra Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc4586-5e62-c9e7-e063-6294a90a276b2025-12-15Exact identifier
application number: M020
20Percent Zinc Total ProtectionZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bcaee1-001b-82da-e063-6394a90a4a0f2025-12-15Exact identifier
application number: M020
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.39821730-f6d1-c01a-e063-6394a90a026b2025-12-15Exact identifier
application number: M020
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984920a-feb9-169c-e063-6394a90a95682025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdf417-45ba-f81a-e063-6394a90a74712025-12-15Exact identifier
application number: M020
Protection E And C Lightly TintedZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bce44e-d9f1-9279-e063-6394a90a64532025-12-15Exact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd148c-43c7-aa93-e063-6394a90abc8b2025-12-15Exact identifier
application number: M020
Glow ShieldZINC OXIDEKristina Lerner35be8766-1352-8967-e063-6294a90a896a2025-12-15Exact identifier
application number: M020
Sheer Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd62d8-ebe3-b3fd-e063-6394a90a827c2025-12-15Exact identifier
application number: M020
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386bb911-9dbb-30fb-e063-6394a90a5e4d2025-12-15Exact identifier
application number: M020
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c0261-68f9-6f27-e063-6294a90a82092025-12-15Exact identifier
application number: M020
PURE Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c320b-22c3-7d35-e063-6394a90a4e0b2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdc7f4-4e47-ce35-e063-6294a90acf2d2025-12-15Exact identifier
application number: M020
Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724cb53-0198-c604-e063-6294a90aa64b2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2046-10003162046105 mL in 1 PACKET (0316-2046-10) 5 ml2020-03-020000-00-00YesNoCurrent
0316-2046-300031620463089 mL in 1 TUBE (0316-2046-30) 89 ml2020-02-170000-00-00NoNoCurrent
0316-2046-310031620463189 mL in 1 TUBE (0316-2046-31) 89 ml2024-12-02NoNoCurrent
0316-2046-4000316204640148 mL in 1 BOTTLE, PLASTIC (0316-2046-40) 148 ml2020-01-290000-00-00NoNoCurrent
0316-2046-4500316204645148 mL in 1 TUBE (0316-2046-45) 148 ml2020-02-170000-00-00NoNoCurrent
0316-2046-4600316204646148 mL in 1 TUBE (0316-2046-46) 148 ml2024-12-02NoNoCurrent
0316-2046-5000316204650259 mL in 1 BOTTLE, PLASTIC (0316-2046-50) 259 ml2020-02-240000-00-00NoNoCurrent
0316-2046-5100316204651259 mL in 1 BOTTLE, PLASTIC (0316-2046-51) 259 ml2025-01-01NoNoCurrent
0316-2046-55003162046555 mL in 1 PACKET (0316-2046-55) 5 ml2025-02-01YesNoCurrent
0316-2046-820031620468230 mL in 1 TUBE (0316-2046-82) 30 ml2025-12-01NoNoCurrent