FDA.reportPublic FDA data

Blue Lizard Sheer SPF 50 Sunscreen

Product NDC
0316-2064
11-digit product format
003162064
Labeler code
0316
Product ID
0316-2064_4833ed53-8e4b-0cdb-e063-6394a90a02ec
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-06
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
66.6; 99.9 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 Sheer SPF 50 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE66.6 mg/mL
TITANIUM DIOXIDE99.9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c20fce25-8120-fe5d-e053-2a95a90a53a0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2064-30Blue Lizard Sheer SPF 50 Sunscreen1 in 1 CARTONLOTION17
0316-2064-30Blue Lizard Sheer SPF 50 Sunscreen89 mL in 1 TUBELOTION897

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2064BLUE LIZARD SHEER SPF 50 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [CROWN LABORATORIES]5Current NDC, Legacy NDC, 2 package rows20231207_c20fce25-8120-fe5d-e053-2a95a90a53a0.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 124 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lip CrackTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37edc05c-82c3-90fe-e063-6294a90aa6012025-12-15Exact identifier
application number: M020
Restore And ReplenishZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ed8525-6ae4-4e86-e063-6294a90afeb82025-12-15Exact identifier
application number: M020
Sunshade Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee77dc-a96a-5efa-e063-6394a90affda2025-12-15Exact identifier
application number: M020
Sunshade Mineral SunscreenZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37df21f1-f36f-df43-e063-6294a90aea6f2025-12-15Exact identifier
application number: M020
Tinted Moisturizing Mineral SunscreenZINC OXIDEEDIT EUROSPA, LLC3751861d-3f3b-2ebd-e063-6294a90af8982025-12-15Exact identifier
application number: M020
Non Tinted Moisturizing Mineral SunscreenZINC OXIDEEDIT EUROSPA, LLC3751e278-b8b2-7bf4-e063-6394a90a42902025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37521c60-2fee-861e-e063-6294a90ad69a2025-12-15Exact identifier
application number: M020
MATTE Non Tinted Mineral SunscreenZINC OXIDEAllure Esthetics3725d947-b1fa-3b50-e063-6394a90adf102025-12-15Exact identifier
application number: M020
GLOW Tinted Mineral SunscreenZINC OXIDEAllure Esthetics37257bb2-d91d-6ff8-e063-6294a90a01b62025-12-15Exact identifier
application number: M020
Daily RestoreZINC OXIDETYRLIN ENTERPRISES, INC.35ce7133-badb-1bc4-e063-6294a90a74782025-12-15Exact identifier
application number: M020
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bee5f9-68d6-6302-e063-6394a90ada882025-12-15Exact identifier
application number: M020
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bfd54a-d7b7-f1a7-e063-6294a90a039b2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c03804-04e9-3d54-e063-6294a90a34072025-12-15Exact identifier
application number: M020
Deflectin Tinted Mineral SunscreenZINC OXIDEAEON AESTHETICS LLC35d14660-8900-2cb0-e063-6394a90a317d2025-12-15Exact identifier
application number: M020
Mineral Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf36c1-50c9-e848-e063-6294a90a66582025-12-15Exact identifier
application number: M020
Flash Invisible StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d2489e-4978-4fc3-e063-6294a90adfcc2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c010ad-e25d-f197-e063-6294a90a0efb2025-12-15Exact identifier
application number: M020
Flash Tinted StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d28590-e746-7996-e063-6294a90ac7d82025-12-15Exact identifier
application number: M020
Mineral Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf03f4-200a-5643-e063-6394a90a9e022025-12-15Exact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf708c-244e-63a8-e063-6394a90a3b962025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2064-30003162064301 TUBE in 1 CARTON (0316-2064-30) / 89 mL in 1 TUBE1 tube2021-05-060000-00-00NoNoCurrent