FDA.reportPublic FDA data

Land Shark SPF 8

Product NDC
52854-928
11-digit product format
528540928
Labeler code
52854
Product ID
52854-928_42c91410-e8d6-7749-e063-6394a90abae0
Type
HUMAN OTC DRUG
Nonproprietary name
octinoxate and oxybenzone
Dosage form
OIL
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-22
Substance
OCTINOXATE; OXYBENZONE
Active strength
5; 2 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 8
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE5 g/100mL
OXYBENZONE2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b5fa2883-998f-2128-e053-2995a90a5c84Available on FDA.report

DailyMed Package Descriptions#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-928LAND SHARK SPF 8 (OCTINOXATE AND OXYBENZONE) OIL [TROPICAL SEAS, INC.]5Current NDC, Legacy NDC, 1 package rows20241103_b5fa2883-998f-2128-e053-2995a90a5c84.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 228 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Classic Body SPF 50 Guava MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed13afaa-35ec-8326-e053-2995a90adaf02025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2102c6-02ea-3a8f-e063-6394a90abf5e2025-02-14WarningsExact identifier
application number: M020
Sunscreen Broad Spectrum SPF 50 Vi AestheticsZINC OXIDE, OCTINOXATEVi Medical Products, INC73620765-c7c0-4bd7-82a9-00022773c9282025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2297d4-3649-a749-e063-6294a90ac2842025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e22cfde-10a1-3742-e063-6394a90ac0972025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2e5c2add-8ed0-a990-e063-6394a90a87ea2025-02-14WarningsExact identifier
application number: M020
Les Duets - Shield of Helios, sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f75a5-6a3b-a129-e063-6394a90a52a02025-02-14WarningsExact identifier
application number: M020
Le Mieux Naked Glow Bronzer SPF 50SUNSCREENYB CHEMIA LLC46465db7-c1f0-6980-e063-6294a90a3ed82025-02-14WarningsExact identifier
application number: M020
Sheer Tint Mineral SPF Serum - Light LightZINC OXIDEMineral Fusion brandsac6fdc35-82f8-4805-875e-2aa91aedec6f2025-02-14WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 50ZINC OXIDEPeer Pharm Ltd.3989eebc-7262-4cda-84a1-ca30b638b7722025-02-13WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 30ZINC OXIDEPeer Pharm Ltd.8ee9f97b-9081-4e0c-aa7a-27a31cbee17a2025-02-13WarningsExact identifier
application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Medium DeepZINC OXIDEPeer Pharm Ltd.45ed56e1-46cb-46de-b11a-e814a7446e572025-02-13WarningsExact identifier
application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Light MediumZINC OXIDEPeer Pharm Ltd.6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a2025-02-13WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Dry Touch SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe99311c2-ed8b-6e60-e053-2a95a90a9bc22025-02-13WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC525f7bae-44b8-44e4-93ea-32995eca25662025-02-13WarningsExact identifier
application number: M020
DreamBeam Sunscreen SunlitSUNSCREEN ZINC OXIDEKosas Cosmetics, LLC2e093b82-2a36-cc0f-e063-6394a90a4d6d2025-02-13WarningsExact identifier
application number: M020
DreamBeam SunscreenSUNSCREEN ZINC OXIDEKosas Cosmetics, LLCf93b0091-6a41-ae6e-e053-6394a90a86d72025-02-13WarningsExact identifier
application number: M020
Revealer Skin-Improving FoundationSUNSCREEN ZINC OXIDEKosas Cosmetics, LLC2e0a0cd6-c302-2017-e063-6394a90a60b82025-02-13WarningsExact identifier
application number: M020
Hi papa KIDS MINERAL FACE SUNSCREENSUNSCREENGUANG DONG 3 INS TECHNOLOGY Co., Ltd2deea723-32a0-da33-e063-6294a90accdd2025-02-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-928-0152854092801250 mL in 1 BOTTLE, PLASTIC (52854-928-01) 250 ml2020-07-220000-00-00NoNoCurrent