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 182 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08f0436b-85b6-5099-e063-6294a90a4c2e2025-10-09WarningsExact identifier
application number: M020
CoreTex Professional Outdoor Skin Protection WalletCORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLETCoreTex Products Incf57bc089-405b-cdcd-e053-2995a90a9d122025-10-09WarningsExact identifier
application number: M020
Mist Me SPF-40ZINC OXIDECove Suncare LLCb7f09089-54a4-4f60-b632-e3f4321313ec2025-10-09WarningsExact identifier
application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
application number: M020
Skinny Dip SPF-50ZINC OXIDECove Suncare LLC7bef2966-9351-4ea6-aeed-0d568376d86b2025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0f0ba2e9-126f-13c0-e063-6394a90aa6a42025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC08997bd4-d6b9-fffc-e063-6294a90a77ae2025-10-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC75f81b2d-cabc-443f-b4b5-76bd2321826b2025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC1390f863-709e-412b-9a25-b65217844e442025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCccc2e40b-5301-4055-8a89-47366687cfb72025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0f0dd2e4-3dda-c872-e063-6294a90a20a32025-10-08WarningsExact identifier
application number: M020
ScalpHair MistSunscreen SPF30COOLA SCALPHAIR MIST ORGANIC SUNSCREEN SPF30COOLA LLCc7d2098f-6fdf-68e5-e053-2a95a90a18982025-10-08WarningsExact identifier
application number: M020
Block Party SPF-50ZINC OXIDECove Suncare LLC24ffb6ec-d922-40c0-b325-c15f8433027a2025-10-08WarningsExact identifier
application number: M020
Sun Kids mineral BLUEBERRY SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDEThe Natural SKN Company40945805-6f2e-74a1-e063-6394a90a04a32025-10-07WarningsExact identifier
application number: M020
ProtecTINT 10NHOMOSALATE, OCTISALATE, ZINC OXIDESupergoop, LLC0801287f-0df5-4303-e063-6394a90a503b2025-10-07WarningsExact identifier
application number: M020
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
application number: M020
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
application number: M020
SPF50 SunscreenSUNSCREENKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDb3cde609-7d62-2ac7-e053-2a95a90a26b32025-10-07Exact identifier
application number: M020
Summer Face Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESUMMER GELEE LLCfe256ff4-cb92-4262-8ab9-7cc912e0af222025-10-06WarningsExact identifier
application number: M020
Sun Veil Broad Spectrum SPF50ZINC OXIDEMONAT GLOBAL CORP3ba28de7-74a2-5cde-e063-6394a90add262025-10-06WarningsExact 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