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 272 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f. Holy Hydration Face Cream SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Incb7898d65-df86-580a-e053-2a95a90a5b1b2024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acda604c-27cf-d500-e053-2995a90a5d652024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acb92160-1749-d51b-e053-2995a90a9e872024-11-06WarningsExact identifier
application number: M020
Bondi Sands Toasted Coconut Lip Balm with SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acb8513e-723b-b7d6-e053-2995a90aed522024-11-06WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free Face SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.acda9863-ad9f-e430-e053-2995a90a69a62024-11-06WarningsExact identifier
application number: M020
Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad SpectrumHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONESEORIN COMPANY Co., Ltd.26442417-f238-1fc3-e063-6394a90a6f822024-11-06WarningsExact identifier
application number: M020
Avene Mineral Sunscreen Face and BodyZINC OXIDEPierre Fabre USA Inc.fb5b1e94-bed3-8486-e053-6294a90a3a842024-11-06WarningsExact identifier
application number: M020
Avene Cleanance Mattifying SPF 30ZINC OXIDEPierre Fabre USA Inc.2644f545-0625-7858-e063-6394a90a59632024-11-06WarningsExact identifier
application number: M020
SPF30 CALENDULA SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY64580be7-868c-40fb-b7b8-840b417b25d32024-11-06WarningsExact identifier
application number: M020
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
application number: M020
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
application number: M020
Vivant Day Treatment SPF 15OCTINOXATE 7.50% OCTISALATE 5.00%Vivant Pharmaceuticals, LLC10a95d0a-366f-0611-e063-6294a90abb442024-11-05WarningsExact identifier
application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.1560a6b6-8d4a-6942-e063-6294a90a4a442024-11-04WarningsExact identifier
application number: M020
Bali Body Watermelon Tanning Oil SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd07d96576-fd78-acf3-e063-6394a90af45b2024-11-03WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Dry-Touch Face and Body Sunscreen Broad Spectrum UVA-UVB SPF 50ZINC OXIDEKenvue Brands LLC8f34c1f6-51fe-4719-ba1f-1e23c05e937b2024-11-01WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCc8d6c731-2dfc-71c0-e053-2a95a90aa5b82024-11-01WarningsExact identifier
application number: M020
Hawaiian Tropic Sport Sunscreen Everyday ActiveAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc64918f-df4c-3a5e-e053-2995a90aea4b2024-11-01WarningsExact identifier
application number: M020
Byoma Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEBYOMA LIMITED25de7939-3b18-7f9e-e063-6394a90a23a92024-11-01WarningsExact identifier
application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.cda67d41-d063-4936-a6b9-23376304eb422024-11-01WarningsExact identifier
application number: M020
Dr Edward Krulig New Melan Sunblock SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEKRULIG INTERNATIONAL, INC21c301d2-b283-40e1-bf26-b4bdde2782472024-10-31WarningsExact 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