FDA.reportPublic FDA data

Land Shark SPF 40

Manufacturer
Tropical Seas, Inc.
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:42:08

Label at a glance#

ProductLand Shark SPF 40
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

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 Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including: limit time in the sun, esp...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 13.0%

Titanium Dioxide 4.2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aqueous extracts of: coconut (cocos nucifera) water, butterfly nectars (buddleja davidii), thymus vulgaris (thyme), lauryl lactate, glyceryl stearate se, phenethyl benzoate, octyl dodecyl citrate crosspolymer, octyl dodecly neopentanoate, cetearyl alcohol, phenoxyethanol (and) caprylyl glycol, benzyl alcohol, ethylhexlglycerin, tocopherol, glycerin, cetyl dimethicone, tricontanyl pvp, cetearyl alcohol & polysorbate-60, xanthan gum, citric acid, cetyl alcohol, perflurodecalin, and fragrance.

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 - 85 g Tube Art

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85g NDC 52854-403-01

85g NDC 52854-403-0185g NDC 52854-403-01

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130079608924032GTIN-13: 0079608924032
EAN-13: 0079608924032
GTIN-12: 079608924032
UPC-A: 079608924032
GTIN storage (14 digits): 00079608924032		SPF40.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-403-01Land Shark SPF 4085 g in 1 TUBELOTION855

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52854-40352854-403-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
TRIACONTANYL PVP (WP-660)N0SS3Q238DIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
THYMUS VULGARIS LEAFGRX3499643IACT
BENZYL ALCOHOLLKG8494WBHIACT
TOCOPHEROLR0ZB2556P8IACT
LAURYL LACTATEG5SU0BFK7OIACT
COCONUT WATER267F5Y81NTIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
WATER059QF0KO0RIACT
BUDDLEJA DAVIDII LEAFX380815D32IACT
GLYCERINPDC6A3C0OXIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PERFLUOROMETHYLDECALINVWJ68OB6TMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYSORBATE 60CAL22UVI4MIACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
XANTHAN GUMTTV12P4NEEIACT
PHENETHYL BENZOATE0C143929GKIACT
OCTYLDODECYL CITRATE CROSSPOLYMERX323T6QO4MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-11-01full-release2026-06-01 00:33:30

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 40ZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d204c38c-b5d1-3511-e053-2a95a90a9dc82025-11-04WarningsExact identifier
ndc (package): 52854-403-01
ndc (product): 52854-403
ndc11 (package): 52854040301
spl id: 42c9ea9f-5a54-f1a4-e063-6294a90a3298
spl set id: d204c38c-b5d1-3511-e053-2a95a90a9dc8

Reported adverse events (FAERS/openFDA)#

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