FDA.reportPublic FDA data

Land Shark SPF 50

Product NDC
52854-951
11-digit product format
528540951
Labeler code
52854
Product ID
52854-951_42ca74ac-48e4-8c1b-e063-6294a90ada87
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octisalate, and avobenzone
Dosage form
SPRAY
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-07
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
b5e24ca1-d041-355d-e053-2995a90a3d61Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-951-01Land Shark SPF 50180 mL in 1 CANSPRAY1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-951LAND SHARK SPF 50 (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [TROPICAL SEAS, INC.]5Current NDC, Legacy NDC, 1 package rows20241103_b5e24ca1-d041-355d-e053-2995a90a3d61.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 218 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5aab267-b33b-a40d-e053-2a95a90a9d792025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5beb9cd-aa3b-2b37-e053-2995a90a84092025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5bdc0c8-af2c-1096-e053-2995a90a89172025-04-01WarningsExact identifier
application number: M020
Mesoestetic Mesoprotech Melan 130 Pigment ControlAVOBENZONE, HOMOSALATE, OCTOCRYLENEMESOESTETIC PHARMA GROUP SL3b50e874-9665-4df4-8b3a-fc932c29f3f62025-04-01WarningsExact identifier
application number: M020
AVON BEYOND GLOW SUN MOISTURIZERAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30c83f4f-9de0-6fbf-e063-6394a90af1ae2025-04-01WarningsExact identifier
application number: M020
EltaMD UV DailyOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6dde7055-5f77-4a7f-a182-c03e1f30bfaa2025-03-31WarningsExact identifier
application number: M020
natural lip balm SPF15( chocolate sundae) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.319e8e26-b29d-4627-e063-6294a90acfba2025-03-31WarningsExact identifier
application number: M020
Face Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEVege Labs31aad575-a5d1-42b0-e063-6294a90a6c812025-03-31WarningsExact identifier
application number: M020
SOLMED SUNSCREEN FACE SHIELDAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENEFEELFREE LLC31b077cc-32b9-78e6-e063-6394a90a155a2025-03-31WarningsExact identifier
application number: M020
TATCHA THE SILK SUNSCREENZINC OXIDETATCHA INC.7799042a-d2de-480e-a8a3-827b3dc279072025-03-31WarningsExact identifier
application number: M020
Cotz Sensitive SPF 40 SunscreenZINC OXIDEFallien Cosmeceuticals, LTD.885a674b-3457-4dfe-a801-529094b004992025-03-31WarningsExact identifier
application number: M020
EltaMD UV Daily TintedOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Incad8aafdf-f3bc-497f-9792-20c2911c12d02025-03-31WarningsExact identifier
application number: M020
EltaMD UV Clear Tinted SPF46ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.1ac59ef1-113e-4ad1-90c3-38353bc7e1ec2025-03-31WarningsExact identifier
application number: M020
lip balm SPF15( CB222) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316416d0-52b5-6f2f-e063-6294a90a9bc12025-03-28WarningsExact identifier
application number: M020
lip balm SPF15( CB400) 01OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316463e0-dc1f-e2ae-e063-6394a90a0c3c2025-03-28WarningsExact identifier
application number: M020
Sunscreen Stick SPF30( CB400) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316498d9-32fe-f884-e063-6394a90a43072025-03-28WarningsExact identifier
application number: M020
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
application number: M020
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
application number: M020
TRADER JOES SHIMMER GLOW SUNSCREEN SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENETrader Joe's Company316c7793-5937-9ce4-e063-6294a90ae0a12025-03-28WarningsExact identifier
application number: M020
CeraVe AM Facial Moisturizing Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDEL'Oreal USA Products Incdc85cff3-df18-4bb7-8d71-bb0878959fe22025-03-28WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-951-0152854095101180 mL in 1 CAN (52854-951-01) 180 ml2020-12-070000-00-00NoNoCurrent