FDA.reportPublic FDA data

Land Shark SPF 50

Product NDC
52854-950
11-digit product format
528540950
Labeler code
52854
Product ID
52854-950_42c997c2-5c4a-56ff-e063-6294a90a15e5
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octisalate, and avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-14
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
10; 5; 3 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Land Shark SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100mL
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4cc95f0-d684-5331-e053-2995a90a3295Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-950-01Land Shark SPF 5060 mL in 1 BOTTLE, PLASTICLOTION606
52854-950-02Land Shark SPF 50120 mL in 1 BOTTLE, PLASTICLOTION1206
52854-950-03Land Shark SPF 50192 mL in 1 BOTTLE, PLASTICLOTION1926
52854-950-04Land Shark SPF 50946 mL in 1 BOTTLE, PUMPLOTION9466
52854-950-05Land Shark SPF 503785 mL in 1 JUGLOTION37856

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-950LAND SHARK SPF 50 (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]5Current NDC, Legacy NDC, 5 package rows20241103_b4cc95f0-d684-5331-e053-2995a90a3295.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 306 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clove Hill acne safe mineral sunscreen SPF 40ZINC OXIDEClove Hill LLCa06e6393-13c5-48b9-909a-3bdf7d58cad32024-01-22WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEA-S Medication Solutionsbfb1fdbe-883f-4d1d-9131-a46da98277882024-01-18WarningsExact identifier
application number: M020
LA Bodies Eclipse Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONESAMSON PHARMACEUTICALce3a5ddc-9d4d-4d63-879c-fc4aef9a0a0a2024-01-18WarningsExact identifier
application number: M020
Shunly Zn20 Light MoisturizerZINC OXIDEShunly Skin Care LLCd5710d48-0a4b-49a6-b6b5-9a192afccd2a2024-01-17WarningsExact identifier
application number: M020
Shunly Zn20 Tinted Light MoisturizerZINC OXIDEShunly Skin Care LLCc046eef3-c2d7-42e6-a5ad-98e513fdb4e12024-01-17WarningsExact identifier
application number: M020
Shunly Radiant Translucent SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC20783833-ee7f-4425-b4ab-ab61cda5b2c82024-01-17WarningsExact identifier
application number: M020
LA Bodies Eclipse Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONESAMSON PHARMACEUTICAL48708273-764d-4139-ae06-7cf1a273759c2024-01-17WarningsExact identifier
application number: M020
Shunly Radiant Translucent Tinted SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC1aeb5e05-730c-4c5c-b164-ad9347b0cd932024-01-17WarningsExact identifier
application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc4a243c9f-ca88-47fb-8777-1da79c001c732024-01-16WarningsExact identifier
application number: M020
NYX Professional Makeup Bare with Me Daily Moisturizing Primer with Cannabis Sativa Seed Oil SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc7f960d4c-ad09-4dc8-b272-66e4df26ace82024-01-16WarningsExact identifier
application number: M020
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREENHOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACIDSled Distribution, LLCec252876-7205-83ec-e053-2a95a90a14632024-01-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDECosmetique Active Productionfd2541e1-c409-40a8-9e3f-6ff69084ea662024-01-15WarningsExact identifier
application number: M020
Lancome Paris Bienfait UV 50 Plus Broad Spectrum SPF 50 Plus Water Resistant 80 Minutes Super Fluid Facial SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc6296fbce-93fe-483e-bd60-6ae228afcaad2024-01-15WarningsExact identifier
application number: M020
LOreal Paris AntiSagging Plus Even Tone Collagen Expert Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Incdb483af0-797b-4ef5-b02a-ab9fa1ba87fe2024-01-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incbc72048a-4786-44c2-97ce-0220822816542024-01-15WarningsExact identifier
application number: M020
Caring mill Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFSA Store Inc.0ec201dc-c262-cecd-e063-6394a90a3fd32024-01-12WarningsExact identifier
application number: M020
Caring mill Kids Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE,FSA Store Inc.0ec21837-d4f1-0916-e063-6294a90a21992024-01-12WarningsExact identifier
application number: M020
CERAMIDE LIFT and FIRM EYE SPF 15OXYBENZONE, OCTINOXATEREVLONb22f0c13-0a9c-7d38-e053-2a95a90a0ecd2024-01-12WarningsExact identifier
application number: M020
Elizabeth Arden, Great 8, Moisturizer SPF 35AVOBENZONE, OCTISALATE, HOMOSALATERevlonb1b89565-7292-45eb-e053-2a95a90ae8d02024-01-12WarningsExact identifier
application number: M020
CERAMIDE LIFT and FIRMOCTINOXATE, OXYBENZONE, AVOBENZONE, OCTISALATE, OCTOCRYLENEREVLONb20ae6e9-de6e-0059-e053-2a95a90a57602024-01-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-950-015285409500160 mL in 1 BOTTLE, PLASTIC (52854-950-01) 60 ml2020-06-290000-00-00NoNoCurrent
52854-950-0252854095002120 mL in 1 BOTTLE, PLASTIC (52854-950-02) 120 ml2020-07-220000-00-00NoNoCurrent
52854-950-0352854095003192 mL in 1 BOTTLE, PLASTIC (52854-950-03) 192 ml2020-02-140000-00-00NoNoCurrent
52854-950-0452854095004946 mL in 1 BOTTLE, PUMP (52854-950-04) 946 ml2020-06-290000-00-00NoNoCurrent
52854-950-05528540950053785 mL in 1 JUG (52854-950-05) 3785 ml2020-06-290000-00-00NoNoCurrent