FDA.reportPublic FDA data

Land Shark SPF 45

Product NDC
52854-945
11-digit product format
528540945
Labeler code
52854
Product ID
52854-945_42c939fa-26c8-56db-e063-6394a90a32b4
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octinoxate, oxybenzone, homosalate and octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-22
Substance
OCTOCRYLENE; OCTINOXATE; OXYBENZONE; HOMOSALATE; OCTISALATE
Active strength
8; 7.5; 6; 5; 5 g/100mL; g/100mL; 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 45
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE8 g/100mL
OCTINOXATE7.5 g/100mL
OXYBENZONE6 g/100mL
HOMOSALATE5 g/100mL
OCTISALATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4cafdf1-44e1-10c0-e053-2995a90ab3dcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-945-01Land Shark SPF 45120 mL in 1 BOTTLE, PLASTICLOTION1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-945LAND SHARK SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.]5Current NDC, Legacy NDC, 1 package rows20241103_b4cafdf1-44e1-10c0-e053-2995a90ab3dc.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 187 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Blueberry Nutri Tint SPF 20 26C Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.733fbb38-1481-415c-8161-18816e87ee4b2025-09-09WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 28W Medium DeepZINC OXIDEDOLCE & GABBANA BEAUTY S.R.L.42d51bd5-0678-4e30-80f7-db10281b95282025-09-09WarningsExact identifier
application number: M020
Sunglaze Body Gel Cream Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC3e6658a1-ae6a-9d19-e063-6294a90acae72025-09-09WarningsExact identifier
application number: M020
CLARINS Extra Firming Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarins57f07e8a-1043-47e4-9d7b-6e78fdc341192025-09-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC1d3218e6-8687-4a94-8bf7-3a867920cd1c2025-09-08WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC6c578ef8-5648-4428-b9a2-0952f96252532025-09-08WarningsExact identifier
application number: M020
Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Sheer Shimmer 10AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC16ac7877-8dfd-3d69-e063-6394a90a5a8a2025-09-08WarningsExact identifier
application number: M020
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD388fb3db-29d2-bb29-e063-6394a90a4efb2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 15N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L8d76a963-bdf5-44a1-b1d6-27d1a3aaa1ae2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 16N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.Ld279693f-2254-4f3c-a121-144f95f9f25d2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 12N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L7f007540-8271-4d85-9d1e-b2b273ca05f82025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 17W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L5198d3df-ffa8-45eb-93d1-11e9f3961b922025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 18N MediumZINC OXIDEDolce & Gabbana Beauty S.R.La82d85c4-c6ef-4083-b67a-2d6b0e8fc10d2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 19W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L4ee6cac6-f649-436c-ada2-e024b86add692025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 24N MediumZINC OXIDEDolce & Gabbana Beauty S.R.Ledd4e8c3-b47a-4cfe-bf20-e856edb76e212025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 21W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L457f0a5c-c543-44f8-82d6-1096a8aab9842025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 22N MediumZINC OXIDEDolce & Gabbana Beauty S.R.L1452ffc4-a83f-472f-ae70-9e1002f889452025-09-08WarningsExact identifier
application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e518d8a-f52b-4ae1-e063-6394a90aaa1e2025-09-08WarningsExact identifier
application number: M020
Ocean Potion Suncare 50 Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3c5a624a-8844-b782-e063-6294a90a478c2025-09-08WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dbb07e2-971c-284d-e063-6294a90a437f2025-09-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-945-0152854094501120 mL in 1 BOTTLE, PLASTIC (52854-945-01) 120 ml2020-07-220000-00-00NoNoCurrent