FDA.reportPublic FDA data

Land Shark SPF 45

Manufacturer
Tropical Seas, Inc.
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:42:02

Label at a glance#

ProductLand Shark SPF 45
Active ingredientOCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE, OCTISALATE
Label structure10 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 8.0%

Octinoxate 7.5%

Oxybenzone 6.0%

Homosalate 5.0%

Octisalate 5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to prevent sunburn, not skin cancer or early skin aging.

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aqueous extracts of: aloe barbadensis leaf extract, algae extract (hawaiian seaplant), chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root & leaf extract, taraxacum officinale (dandelion) leaf extract, echinacea purpurea (coneflower) extract, sambucus nigra (elder) flower extract, panax quinquefolium (ginseng) root extract, macrocystis pyrifera (kelp) extract, lavandula angustifolia (lavender) extract, cymbopogon schoenanthus (lemon grass) extract, althea officinalis (marshmallow) root extract, achillea millefolium (yarrow flower) extract, camellia sinensis (white tea) extract, stearic acid (vegetable derived), glyceryl stearate se (vegetable derived), titanium dioxide, cetyl dimethicone, glycerin (coconut derived), sodium hydroxide, emulsifying wax (vegetable derived), tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, methylparaben, cetyl alcohol (vegetable derived), diazolidinyl urea and propylparaben.

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-368-7327

Principal Display Panel - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

back label 120mlback label 120ml120 ml NDC: 52854-945-01 120 ml front label120 ml front label

DailyMed Package Descriptions#

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52854-94552854-945-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARRAGEENAN5C69YCD2YJIACT
CHAMOMILEFGL3685T2XIACT
SYMPHYTUM UPLANDICUM LEAFD05HXK6R3GIACT
COMFREY ROOTM9VVZ08EKQIACT
TARAXACUM OFFICINALE LEAF0022LFJ74YIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXIACT
SAMBUCUS NIGRA FLOWER07V4DX094TIACT
AMERICAN GINSENG8W75VCV53QIACT
MACROCYSTIS PYRIFERAK31S3OG5C4IACT
LAVANDULA ANGUSTIFOLIA FLOWERING TOP9YT4B71U8PIACT
CYMBOPOGON SCHOENANTHUS TOP9SJI1LW39WIACT
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
TRICONTANYL POVIDONEN0SS3Q238DIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
METHYLPARABENA2I8C7HI9TIACT
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLPARABENZ8IX2SC1OHIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-01full-release2026-06-01 00:33:27

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Land Shark SPF 45OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATETropical Seas, Inc.b4cafdf1-44e1-10c0-e053-2995a90ab3dc2025-11-04WarningsExact identifier
ndc (package): 52854-945-01
ndc (product): 52854-945
ndc11 (package): 52854094501
spl id: 42c939fa-26c8-56db-e063-6394a90a32b4
spl set id: b4cafdf1-44e1-10c0-e053-2995a90ab3dc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.