HAWAIIAN TROPIC

Product NDC
63354-355
11-digit product format
633540355
Labeler code
63354
Product ID
63354-355_5de311d2-58ac-4fac-e063-6394a90ae9ec
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Homosalate,Octisalate,Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-06
Marketing end
2028-10-01
Substance
OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
4.5; 2; 5.5; 4 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
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
HAWAIIAN TROPIC

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4.5 g/100g
AVOBENZONE2 g/100g
HOMOSALATE5.5 g/100g
OCTOCRYLENE4 g/100g

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 170 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e4e63c-3e51-0a78-e053-2a95a90abd872025-11-04WarningsExact identifier
application number: M020
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.8cd68b09-2578-4519-b00e-e83e0e4408152025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e44be7-3a46-34e2-e053-2a95a90a96602025-11-04WarningsExact identifier
application number: M020
Reef Kids SPF 30 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.005a9e7c-e392-4b9a-911f-d7586f7ae94e2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559d349-2ffd-492c-e053-2995a90aab062025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pink BeachZINC OXIDETropical Seas, Inc.d240e6c9-d053-9924-e053-2a95a90a855a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 15OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e49c6f-477b-aafc-e053-2a95a90a982a2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559e03b-f5d3-bd72-e053-2995a90a31ca2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30 Clear ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d128269b-73fa-e5f3-e053-2995a90af1ed2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50 SportOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e40a7c-b49d-cfc3-e053-2995a90ac27e2025-11-04WarningsExact identifier
application number: M020
Reef Babies SPF 50 Oxybenzone FreeOCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.d5ed3488-aa32-4a63-9996-12c6532c3a4d2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b559499c-6109-bf5e-e053-2995a90a4ac72025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5e24ca1-d041-355d-e053-2995a90a3d612025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.b5570cbd-89f5-65d5-e053-2995a90a54d12025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Azure BlueZINC OXIDETropical Seas, Inc.d23fe61a-3ffb-59d0-e053-2995a90a59e62025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.b55a0bd0-2a32-2977-e053-2a95a90aa1422025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 30OCTOCRYLENE, OCTISALATE, AVOBENZONETropical Seas, Inc.06d43525-86d8-f2d9-e063-6394a90afc812025-11-04WarningsExact identifier
application number: M020
Land Shark Zinky SPF 36 Pacific PurpleZINC OXIDETropical Seas, Inc.d240fe7c-9d16-78c9-e053-2a95a90a763c2025-11-04WarningsExact identifier
application number: M020
Expedition BackCountry SPF 50OCTOCRYLENE, OCTISALATE, AND AVOBENZONETropical Seas, Inc.06c1ac52-474c-db5c-e063-6294a90afb5f2025-11-04WarningsExact identifier
application number: M020
Land Shark SPF 30 Tinted ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d1287899-f178-6124-e053-2a95a90a95a52025-11-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-355-5463354035554177 g in 1 BOTTLE (63354-355-54) 177 g2026-01-062028-10-01NoNoHistorical