FDA.reportPublic FDA data

Land Shark SPF 20

Product NDC
52854-920
11-digit product format
528540920
Labeler code
52854
Product ID
52854-920_42c9a4eb-f42b-268f-e063-6394a90afcd7
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
2020-07-22
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
3; 2; 1 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 20
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE3 g/100mL
OCTISALATE2 g/100mL
AVOBENZONE1 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
b55792e6-2ead-1fb1-e053-2995a90ac915Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-920-01Land Shark SPF 20120 mL in 1 BOTTLE, PLASTICLOTION1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-920LAND SHARK SPF 20 (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]5Current NDC, Legacy NDC, 1 package rows20241103_b55792e6-2ead-1fb1-e053-2995a90ac915.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 300 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC37d696d9-f89d-498e-8fe9-1f08d05d7b612024-04-18WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 50OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDEGalderma Laboratories, L.P.6650d137-e69e-4ec2-8311-3de74bf213152024-04-17WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Berry SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEco Lips. Inc.e5e84e60-4339-460d-e053-2a95a90ad1522024-04-17WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Mint SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEco Lips. Inc.e64c4a2d-134e-999a-e053-2a95a90a64ee2024-04-17WarningsExact identifier
application number: M020
SPF 30 Mineral Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC0bc21573-d302-4d85-8d8f-dca9a48e1f352024-04-17WarningsExact identifier
application number: M020
Differin Oil Absorbing Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.4d5978c7-3575-4b5b-97bd-5f3c89412baf2024-04-17WarningsExact identifier
application number: M020
Cancer Council Everyday Active SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.16381c8f-f954-f0be-e063-6394a90ae4012024-04-16WarningsExact identifier
application number: M020
The Nethercutt Collection Sunscreen Stick SPF 30 Broad Spectrum Sunscreen SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.163a2994-d95a-5752-e063-6394a90aec5d2024-04-16WarningsExact identifier
application number: M020
The Nethercutt Collection Hemp Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.163ac1c1-7403-9d60-e063-6294a90a1cc02024-04-16WarningsExact identifier
application number: M020
CetaphilOCTOCRYLENE, AVOBENZONEGalderma Laboratories, L.P.2a6bc3f2-4e52-252b-d051-94be1ee0cc002024-04-16WarningsExact identifier
application number: M020
Cetaphil Oil Absorbing SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.73ed545b-460f-4287-8643-a02b0641fd452024-04-16WarningsExact identifier
application number: M020
SUN CONTROL BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, ZINC OXIDESKINPLAN.US LLC8e34a343-7253-469f-9973-076a7ae26cbc2024-04-15WarningsExact identifier
application number: M020
Cancer Council Protect and Hydrate Radiance SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1622c351-6e69-eeaf-e063-6294a90acd252024-04-15WarningsExact identifier
application number: M020
Hydrating Mineral Sunscreen BS SPF30ZINC OXIDEAllure Labs16268c31-2151-20e0-e063-6294a90a79652024-04-15WarningsExact identifier
application number: M020
Cancer Council Daily Body Moisturizer SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.16296d3e-286a-e015-e063-6394a90a41892024-04-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Productionf9645435-e138-45df-a5ec-6dc7b3ff792d2024-04-08WarningsExact identifier
application number: M020
Degil Sun SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENEDegil Safety Products (1989) Inc155aa0c5-6403-ee86-e063-6294a90a1c4d2024-04-05WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip SPF 15 AssortedHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.ff9eae5b-4963-429d-bb73-8e3b5402f0842024-04-05WarningsExact identifier
application number: M020
Lemongrass Spa Products SPF 45 Mineral SunscreenZINC OXIDELemongrass Spa Products15469260-d4e5-8423-e063-6394a90aafae2024-04-04WarningsExact identifier
application number: M020
Clearly Zinq Tinted Hydrating Facial SPF Growth Factor 35ZINC OXIDEAllure Labs1548faf9-8623-f871-e063-6394a90a931f2024-04-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-920-0152854092001120 mL in 1 BOTTLE, PLASTIC (52854-920-01) 120 ml2020-07-220000-00-00NoNoCurrent