FDA.reportPublic FDA data

HAWAIIAN TROPIC

Product NDC
63354-784
11-digit product format
633540784
Labeler code
63354
Product ID
63354-784_3fe83a06-b046-ac3b-e063-6294a90a3b37
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,OCTISALATE,OCTOCRYLENE
Dosage form
OIL
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-02
Substance
OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength
4.5; 2.7; 9 g/100g; g/100g; g/100g
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
HAWAIIAN TROPIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4.5 g/100g
AVOBENZONE2.7 g/100g
OCTOCRYLENE9 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31d01fae-4085-d84a-e063-6294a90ab981Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-784-16HAWAIIAN TROPIC236 g in 1 BOTTLE, PUMPOIL2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-784HAWAIIAN TROPIC (AVOBENZONE,OCTISALATE,OCTOCRYLENE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]1Current NDC, 1 package rows20250406_31d01fae-4085-d84a-e063-6294a90ab981.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 274 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f540b0f6-3e6c-43a7-e053-2a95a90aba742024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f4481bf3-6dc7-5641-e053-2a95a90ad9382024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town CityLIP BALM SPF 30 SUNSCREEN STICKFruit of the Earth, Inc.3ec16996-ae86-4f5b-b1fd-c7b509cc5d502024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Mentha and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f452df0c-ea8d-e25c-e053-2995a90a11432024-10-18WarningsExact identifier
application number: M020
FRUIT OF THE EARTH 100 DRY TOUCH BROAD SPECTRUM SPF 100 FACE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEFRUIT OF THE EARTH, INC.fa18f1a9-7a6a-856e-e053-6294a90aeafa2024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Blood Orange and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f452f94a-d2f1-60ec-e053-2995a90a88272024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f45d25d2-9305-5858-e053-2a95a90a7f7b2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f53fff7a-ef8b-19c4-e053-2a95a90a4a2a2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEFruit Of The Earth, Inc.fd68012d-814b-ac07-e053-6394a90afc682024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd687b34-e4c6-0458-e053-6394a90ac0642024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd786a06-88b7-fa35-e053-6394a90a84a52024-10-18WarningsExact identifier
application number: M020
Chemical Sunscreen SPF50 with AntipollutionHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREENSwiss-American CDMO, LLC59efb7dd-83f9-4222-9b7e-ea17ac4ece002024-10-18WarningsExact identifier
application number: M020
CVS Health SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyf0d6ac48-3d57-0f5c-e053-2a95a90a87cf2024-10-17WarningsExact identifier
application number: M020
CVS HEALTH SPORT SPF 50 CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf13f7361-56b3-7ea8-e053-2995a90a76412024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 50 Ultra ProtectionAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf11650bb-90a0-78a1-e053-2995a90a8e4c2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacyf31dd448-dc79-21f1-e053-2a95a90a7bb62024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Breakout Free FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41478c8-76c0-727f-e053-2a95a90a86692024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra ProtectionAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf12ba764-afea-3f81-e053-2a95a90a12912024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf32ec4ef-352e-6a78-e053-2995a90af4912024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf40e5664-e3ca-badf-e053-2a95a90a913e2024-10-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-784-1663354078416236 g in 1 BOTTLE, PUMP (63354-784-16) 236 g2025-04-02NoNoCurrent