FDA.reportPublic FDA data

Land Shark SPF 30

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 01:42:03

Label at a glance#

ProductLand Shark SPF 30
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure8 sections

Indications and uses

helps prevent sunburn helps prevent chapped or cracked skin

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

Octocrylene 5.0%

Octisalate 3.0%

Avobenzone 2.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • helps prevent chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only *Keep out of eyes

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.

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

ricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) fruit oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, flavor, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, flavor, glyceryl stearate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, cocos nucifera (coconut) fruit extract, octyldodecyl neopentanoate, cetyl dimethicone, hippophae rhamnoides (sea buckthorn) oil.

Principal Display Panel - Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4.44g NDC 52854-981-01

4.44gm label4.44gm label

4.44g NDC 52854-981-01 Blister Card Front

4.44g NDC 52854-981-01 Blister Card Front4.44g NDC 52854-981-01 Blister Card Front

4.44g NDC 52854-981-01 Blister Card Back

4.44g NDC 52854-981-01 Blister Card Back4.44g NDC 52854-981-01 Blister Card Back

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130079608930811GTIN-13: 0079608930811
EAN-13: 0079608930811
GTIN-12: 079608930811
UPC-A: 079608930811
GTIN storage (14 digits): 00079608930811		lipbalmsangria_blister_back.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-981-01Land Shark SPF 304.44 g in 1 TUBELIPSTICK4.446

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52854-98152854-981-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
LAURYL LAURATEGPW77G0937IACT
OLIVE OIL6UYK2W1W1EIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
CANDELILLA WAXWL0328HX19IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PHENETHYL BENZOATE0C143929GKIACT
COCONUT3RT3536DHYIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-01full-release2026-06-01 00:33:28

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 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559499c-6109-bf5e-e053-2995a90a4ac72025-11-04WarningsExact identifier
ndc (package): 52854-981-01
ndc (product): 52854-981
ndc11 (package): 52854098101
spl id: 42ca5edc-f01e-7e06-e063-6294a90a88ba
spl set id: b559499c-6109-bf5e-e053-2995a90a4ac7

Reported adverse events (FAERS/openFDA)#

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