Blue Lizard Sport SPF 50 Sunscreen

Product NDC
0316-2075
11-digit product format
003162075
Labeler code
0316
Product ID
0316-2075_50c4e0bf-354b-c1d1-e063-6394a90a8fee
Type
HUMAN OTC DRUG
Nonproprietary name
Octisalate and Titanium Dioxide and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-09
Substance
OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
55.5; 59.5; 111 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0316-20750316-2075-30DDiscontinued by firm2026-10-23
excluded packagepackage0316-20750316-2075-40DDiscontinued by firm2026-10-23
excluded packagepackage0316-20750316-2075-45DDiscontinued by firm2026-10-23
excluded packagepackage0316-20750316-2075-50DDiscontinued by firm2026-10-23

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 · 14 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050316-2075-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050316-2075-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260316-2075-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260316-2075-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310316-2075-452ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280316-2075-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210316-2075-45cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100316-2075-45cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310316-2075-45302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200316-2075-45ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100316-2075-450efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080316-2075-45ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030316-2075-45367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090316-2075-45557ba5c1ecfa…9c80585c8c6e…

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 Sport SPF 50 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE55.5 mg/mL
TITANIUM DIOXIDE59.5 mg/mL
ZINC OXIDE111 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
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
4955fa1c-789d-4f42-af75-70223310644aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2075-30Blue Lizard Sport SPF 50 Sunscreen89 mL in 1 TUBELOTION898
0316-2075-40Blue Lizard Sport SPF 50 Sunscreen148 mL in 1 BOTTLE, PLASTICLOTION1488
0316-2075-40Blue Lizard Sport SPF 50 Sunscreen1 in 1 CARTONLOTION18
0316-2075-45Blue Lizard Sport SPF 50 Sunscreen148 mL in 1 TUBELOTION1488
0316-2075-50Blue Lizard Sport SPF 50 Sunscreen259 mL in 1 BOTTLE, PLASTICLOTION2598

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2075BLUE LIZARD SPORT SPF 50 SUNSCREEN (OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]4Current NDC, Legacy NDC, 5 package rows20231205_4955fa1c-789d-4f42-af75-70223310644a.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 96 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Sport Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd46052d3-6f45-5f4d-e053-2995a90a87602025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc5dafd4-dfd4-d310-e053-2995a90a82a82025-12-31WarningsExact identifier
application number: M020
Coppertone EveryTone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Inc04c58384-fd82-f6d0-e063-6294a90a3ff12025-12-31WarningsExact identifier
application number: M020
Coppertone Sport SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdort Inccc46b3a3-48f5-4593-e053-2995a90a87822025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sport SPF 60 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb7304-789d-1f94-e063-6394a90a7e622025-12-31WarningsExact identifier
application number: M020
Coppertone Kids SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccbf9a785-f218-76fb-e053-2995a90a8e032025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60c2a38-ef92-0dff-e053-2995a90a47c42025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30(TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a5370-ec6f-42a7-e063-6394a90ac37c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd53e1253-f6a4-4f3d-e053-2a95a90a79ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Face SPF 60 Plus SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc04b36eb1-bffc-c31e-e063-6294a90a8eb32025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd47460a1-4768-ee44-e053-2a95a90adecf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50ZINC OXIDE 20%Beiersdorf Incd46359e7-b585-c43a-e053-2995a90a08632025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd473e7ed-4a9f-76fe-e053-2995a90ab37d2025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incf3e3f4c6-2cb9-7b17-e053-2a95a90a38542025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Age Defense Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23f88c88-b68e-4706-e063-6294a90afb382025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd473113d-2fc3-6b1c-e053-2a95a90a88ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Incd89df7a5-7741-3e1d-e053-2995a90ae2752025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd475e14f-dab1-dec5-e053-2995a90aef732025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd4757d99-bac6-48fb-e053-2a95a90ab1bf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc24d3fbbc-0bce-b47a-e063-6394a90a9afa2025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2075-300031620753089 mL in 1 TUBE (0316-2075-30) 89 ml2021-02-090000-00-00NoNoCurrent
0316-2075-40003162075401 BOTTLE, PLASTIC in 1 CARTON (0316-2075-40) > 148 mL in 1 BOTTLE, PLASTIC2021-03-040000-00-00NoNoCurrent
0316-2075-4500316207545148 mL in 1 TUBE (0316-2075-45) 148 ml2021-05-010000-00-00NoNoCurrent
0316-2075-5000316207550259 mL in 1 BOTTLE, PLASTIC (0316-2075-50) 259 ml2021-05-010000-00-00NoNoCurrent