FDA.reportPublic FDA data

HAWAIIAN TROPIC

Product NDC
63354-593
11-digit product format
633540593
Labeler code
63354
Product ID
63354-593_5de3805f-8ee3-971d-e063-6294a90a6aa9
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,OCTOCRYLENE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-31
Marketing end
2028-10-01
Substance
OCTOCRYLENE; AVOBENZONE
Active strength
3; 1 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
OCTOCRYLENE3 g/100g
AVOBENZONE1 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-593-16HAWAIIAN TROPIC236 g in 1 BOTTLE, PUMPSPRAY2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-593HAWAIIAN TROPIC (AVOBENZONE,OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]1Current NDC, 1 package rows20231031_08f34b31-6337-ef7c-e063-6294a90a1c4c.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 95 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Kids Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc068a6e7-260f-0766-e053-2995a90a422f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccc43f433-51ff-ed6a-e053-2a95a90ad3c52025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb5bb6eb6-3356-e2a5-e053-2995a90aa6842025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incccbf7795-e153-1a43-e053-2a95a90ad4b62025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd9cbdb4-42f1-3063-e053-2a95a90a08aa2025-12-31WarningsExact identifier
application number: M020
Eucerin Baby Sensitive Mineral SPF 50 SunscreenZINC OXIDEBeiersdorf Inccdb19c82-9845-eabc-e053-2a95a90a31f72025-12-31WarningsExact identifier
application number: M020
Eucerin Advance Hydration Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd61e4d7-776d-8d84-e053-2995a90a48192025-12-31WarningsExact identifier
application number: M020
Eucerin Oil-Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccda04484-ba84-2276-e053-2a95a90a41c82025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-593-1663354059316236 g in 1 BOTTLE, PUMP (63354-593-16) 236 g2023-10-312028-10-01NoNoHistorical