FDA.reportPublic FDA data

Land Shark SPF 8

Product NDC
52854-908
Requested package NDC
52854-908-01
11-digit product format
528540908
Labeler code
52854
Product ID
52854-908_42c9df65-9604-6288-e063-6394a90a8a30
Type
HUMAN OTC DRUG
Nonproprietary name
octinoxate and oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-22
Substance
OCTINOXATE; OXYBENZONE
Active strength
4.5; 1.5 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
OCTINOXATE4.5 g/100mL
OXYBENZONE1.5 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
b5e68448-4131-1c6c-e053-2a95a90a014aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-908-01Land Shark SPF 8192 mL in 1 BOTTLE, PLASTICLOTION1926

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-908LAND SHARK SPF 8 (OCTINOXATE AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.]5Current NDC, Legacy NDC, 1 package rows20241103_b5e68448-4131-1c6c-e053-2a95a90a014a.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 74 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANUA INVISIBLE MATTE FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.4248deaf-ad55-a9b4-e063-6294a90a55cc2026-01-19WarningsExact identifier
application number: M020
ONSART Mineral SunscreenZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.48c9d08d-9a91-7df5-e063-6294a90a1c4a2026-01-19WarningsExact identifier
application number: M020
Intense Moisture Day CreamAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENECVS Health795d3546-f0dd-4b54-9807-9cdb3e6261812026-01-19WarningsExact identifier
application number: M020
CURESHIELD MANICURE SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD48b4fad7-073d-d983-e063-6394a90ae3142026-01-18WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65ff0448-17e6-42ce-989a-940794fcbd8c2026-01-17WarningsExact identifier
application number: M020
BenzoAzeline 10BENZOYL PEROXIDENoon Aesthetics M.R. Ltd985efa19-bd91-45cd-a2a0-d71ec325e51c2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Berry SPF 30PREQUEL LIP VISOR BERRY SPF 30The Center Brands, LLCe4f3a0eb-4a8c-4145-92e4-979f03e3a5112026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Blush SPF 30PREQUEL LIP VISOR BLUSH SPF 30The Center Brands, LLCbc681245-e158-4cfa-9718-7ec4cff0e60d2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Mahogany SPF 30PREQUEL LIP VISOR MAHOGANY SPF 30The Center Brands, LLCea8dcd14-3c54-46a6-aabc-3655f051065b2026-01-16WarningsExact identifier
application number: M020
Prequel Lip Visor Nude SPF 30PREQUEL LIP VISOR NUDE SPF 30The Center Brands, LLC03a7c77d-7b6e-4720-88f1-492ce57c71452026-01-16WarningsExact identifier
application number: M020
Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30ZINC OXIDECVL Cosmetics North America Incf3057856-1461-41d3-a5c4-9f12e3a4a0ee2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior04e9c4d8-1600-4ffc-8578-4ffb82b106f32026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1aae19da-1e73-41ed-91dc-0746ad311b872026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior22d4452d-3798-48c6-a7a4-4af0f99b4ebd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord6800bb7-16ef-48f6-a09a-0422e64ad8bd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorfb9cfd4f-a558-4df2-bbbf-b814ae19a1352026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9ddcda6-3d87-4197-a2c2-5b30016d32eb2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior25abef37-1726-491f-8a11-ac1a96378ed12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb0e315b3-a322-4607-b212-bcadd5aa99bc2026-01-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-908-0152854090801192 mL in 1 BOTTLE, PLASTIC (52854-908-01) 192 ml2020-07-220000-00-00NoNoCurrent