FDA.reportPublic FDA data

Land Shark SPF 50

Product NDC
52854-950
11-digit product format
528540950
Labeler code
52854
Product ID
52854-950_42c997c2-5c4a-56ff-e063-6294a90a15e5
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octisalate, and avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-14
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
10; 5; 3 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 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100mL
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4cc95f0-d684-5331-e053-2995a90a3295Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-950-01Land Shark SPF 5060 mL in 1 BOTTLE, PLASTICLOTION606
52854-950-02Land Shark SPF 50120 mL in 1 BOTTLE, PLASTICLOTION1206
52854-950-03Land Shark SPF 50192 mL in 1 BOTTLE, PLASTICLOTION1926
52854-950-04Land Shark SPF 50946 mL in 1 BOTTLE, PUMPLOTION9466
52854-950-05Land Shark SPF 503785 mL in 1 JUGLOTION37856

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-950LAND SHARK SPF 50 (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]5Current NDC, Legacy NDC, 5 package rows20241103_b4cc95f0-d684-5331-e053-2995a90a3295.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 267 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d8551c6-2efe-11a8-e063-6294a90aed012024-12-01WarningsExact identifier
application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d958343-31e3-0b7a-e063-6294a90a424a2024-12-01WarningsExact identifier
application number: M020
Attitude Kids mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Qubec Inc. DBA Attitudec2461e22-1518-4f9e-ad8c-951784ef8b5f2024-12-01WarningsExact identifier
application number: M020
BIO SPECTRA ATTITUDEZINC OXIDE9055-7588 Quebec Inc. DBA Attitude954713fe-c84c-41b4-913d-3507ed91e55d2024-12-01WarningsExact identifier
application number: M020
CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDECaudalie USA, Inc.150e3bf3-7b05-e611-e063-6294a90a09322024-11-29WarningsExact identifier
application number: M020
CLEARING DEFENSE SPF30OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.2cb559d3-dd79-4951-ad38-190fd4dd7c402024-11-27WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC1ccde0bc-08aa-8a25-e063-6394a90a27622024-11-25WarningsExact identifier
application number: M020
Girlyish Skincare Mineral Sunscreen SPF 30ZINC OXIDERise Skincare LLC137ba0be-91ce-4bd0-9713-57b1693597502024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 9NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior95d657e5-cf89-48dd-a12e-f9664b131eb92024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior33f42840-92f8-4fa1-86e9-ec0a06d637de2024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior20785934-e534-4ea5-8c15-f9669b0421532024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore4464601-a9ec-413b-a883-9efe61f2f5b22024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 8NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5e7c879c-1e5c-4614-bec1-d363978c3b0d2024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5c1f1f09-19fb-4ceb-bb6d-22d51b5733a82024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc8a48759-efac-47ac-972a-c994b6774e202024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior793c18e5-4363-45b0-a184-0b6c69a91b2c2024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8a542b3c-c3c0-465a-9b24-6a62016656f32024-11-25WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CLARO 110COCTINOXATE, ZINC OXIDEBEL STAR S A27c30645-dcef-bc31-e063-6394a90a13682024-11-25WarningsExact identifier
application number: M020
SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15OCTINOXATE AND TITANIUM DIOXIDEBobbi Brown Professional Cosmetics Inc.b669c36d-4c94-455d-8534-9c3bb024d6682024-11-25WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands, LLC8a1eefa6-619e-5d02-e053-2995a90a3d752024-11-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-950-015285409500160 mL in 1 BOTTLE, PLASTIC (52854-950-01) 60 ml2020-06-290000-00-00NoNoCurrent
52854-950-0252854095002120 mL in 1 BOTTLE, PLASTIC (52854-950-02) 120 ml2020-07-220000-00-00NoNoCurrent
52854-950-0352854095003192 mL in 1 BOTTLE, PLASTIC (52854-950-03) 192 ml2020-02-140000-00-00NoNoCurrent
52854-950-0452854095004946 mL in 1 BOTTLE, PUMP (52854-950-04) 946 ml2020-06-290000-00-00NoNoCurrent
52854-950-05528540950053785 mL in 1 JUG (52854-950-05) 3785 ml2020-06-290000-00-00NoNoCurrent