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 326 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3WOCTISALATE, TITANIUM DIOXIDEGuerlain15fe0429-720c-4975-953d-285aa7ee12ce2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4WOCTISALATE, TITANIUM DIOXIDEGuerlain1a733548-75a4-41ec-8d8d-3e6e9aad52e02023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8NOCTISALATE, TITANIUM DIOXIDEGuerlainf43c867a-161f-47b7-b3d8-7f7e6c6728042023-11-08WarningsExact identifier
application number: M020
Aruba Sun SPF 70 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd96b4233-6d52-7621-e053-2a95a90a1b602023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0COCTISALATE, TITANIUM DIOXIDEGuerlain0d75be99-7607-4964-bb6e-3c731644ab4e2023-11-08WarningsExact identifier
application number: M020
Dead Sea Natural Face Moisturizer Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltddee4bdb8-5c6f-42f6-b15c-d109cd2d31402023-11-08WarningsExact identifier
application number: M020
Mineral Radiance Energizing Day BS SPF 15AVOBENZONE, HOMOSALATE, AND OCTISALATEAHAVA Dead Sea Laboratories Ltd4cb8b21c-7727-441a-9d61-c90d79ac45dc2023-11-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm Passion FruitAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLCf34beb68-e5dc-45c4-a6d1-e9a0310162282023-11-08WarningsExact identifier
application number: M020
Private Label SPF45 Water Resistant Paraben Free SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCf997f4fc-7da5-433c-9a53-2030b489b4f62023-11-07WarningsExact identifier
application number: M020
Private Label Moisturizing Oil Free Paraben Free SPF43SUNSCREENSwiss-American CDMO, LLC003e4221-f9d9-47c4-b10b-9876046b931a2023-11-07WarningsExact identifier
application number: M020
AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15AVOBENZONE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltd5a9ec221-a9ec-4473-8fb0-83f10ae775e22023-11-07WarningsExact identifier
application number: M020
Private Label Super Light Oil-Free SPF452.75% OCTINSALATE, 7.50% OCTINOXATE, 8.00% ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC6a08448a-46bc-4330-ae2d-f716bb4edfa72023-11-07WarningsExact identifier
application number: M020
GOLD MOUNTAIN BEAUTY Collagen Broad Spectrum SPF 30OCTINOXATE, OCTISALATE, ZINC OXIDETT Fitness, Inc617ef3af-4203-4664-b714-1b5fab2e0ee62023-11-06WarningsExact identifier
application number: M020
SEAWEED BATH CO. Clear Moisture Mineral SPF-30ZINC OXIDEThe Seaweed Bath Co.c241261c-d887-4ac2-89ce-93dcc0fce2672023-11-06WarningsExact identifier
application number: M020
JESS BEAUTY Let It Sun Sunscreen SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC88628c11-dbc7-4404-9701-7944a685a13d2023-11-06WarningsExact identifier
application number: M020
SEAWEED BATH CO. Sheer Mineral Sensitive SPF-50ZINC OXIDEThe Seaweed Bath Co.fdcfc7eb-da33-4461-a4f9-fe97ea6b873f2023-11-06WarningsExact identifier
application number: M020
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42TITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC82d210bc-b7ca-4d74-be58-85f175a750582023-11-06WarningsExact identifier
application number: M020
CALIFORNIA MANGO SPF-50 SUNSCREENAVOBENZONE, OCTISALATE, OCTOCRYLENECALMANGO, INC183e523a-93ee-47ec-8bd4-5557af449ea52023-11-06WarningsExact identifier
application number: M020
Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDENEWCO LLCfa3c73a3-0dfb-4673-822a-45d946dee2602023-11-06WarningsExact identifier
application number: M020
JESS BEAUTY Sun Drops Sunscreen Oil SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC4e05e9d6-5127-44ca-a331-3004b2ddb5342023-11-06WarningsExact 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