FDA.reportPublic FDA data

Land Shark SPF 8

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 01:42:05

Label at a glance#

ProductLand Shark SPF 8
Active ingredientOCTINOXATE, OXYBENZONE
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

Octinoxate 5.0%

Oxybenzone 2.0%

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

mineral oil, ethylhexyl palmitate, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) oil, theobroma cacao (cocoa) seed butter, fragrance, and propylparaben.

Other Information

SPL UNCLASSIFIED SECTION

  • hold apprximately 10 - 12 inches from skin to spray
  • spray into palm of hand, rub together, then apply to your face
  • do not spray directly into your face so that it won't get in your eyes.
  • rub into skin evenly to ensure appropriate coverage
  • this product provides minimum sunburn protection
  • fair skin types should use a higher spf
  • protect this product from excessive cold, 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

250 ml NDC: 52854-928-01 250ml label250ml label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-928-01Land Shark SPF 8250 mL in 1 BOTTLE, PLASTICOIL2506

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52854-92852854-928-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
ETHYLHEXYL PALMITATE2865993309IACT
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL724GKU717MIACT
PROPYLPARABENZ8IX2SC1OHIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
COCOA BUTTER512OYT1CRRIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-01full-release2026-06-01 00:33:29

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 8OCTINOXATE AND OXYBENZONETropical Seas, Inc.b5fa2883-998f-2128-e053-2995a90a5c842025-11-04WarningsExact identifier
ndc (package): 52854-928-01
ndc (product): 52854-928
ndc11 (package): 52854092801
spl id: 42c91410-e8d6-7749-e063-6394a90abae0
spl set id: b5fa2883-998f-2128-e053-2995a90a5c84

Reported adverse events (FAERS/openFDA)#

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