FDA.reportPublic FDA data

HAWAIIAN TROPIC

Product NDC
63354-613
11-digit product format
633540613
Labeler code
63354
Product ID
63354-613_3fe8332b-e3f9-a32c-e063-6294a90a252a
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-31
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
2; 6; 6; 4.5 g/100g; 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
AVOBENZONE2 g/100g
HOMOSALATE6 g/100g
OCTOCRYLENE6 g/100g
OCTISALATE4.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08f3b27f-b233-d406-e063-6394a90ada76Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-613-34HAWAIIAN TROPIC170 g in 1 CANAEROSOL, SPRAY1703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-613HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) AEROSOL, SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]2Current NDC, 1 package rows20250410_08f3b27f-b233-d406-e063-6394a90ada76.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 165 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEPILLOWTALKDERM LLC30e10a62-8430-649b-e063-6394a90a97eb2025-11-11WarningsExact identifier
application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTEDTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.279a5214-79b2-44e9-b003-378d0b9923952025-11-11WarningsExact identifier
application number: M020
Tinted Moisturizer SPF 46 Universal TintZINC OXIDE, OCTINOXATEDrmtlgy, LLC5304b568-f891-4094-9182-363ae7bcfbe42025-11-11WarningsExact identifier
application number: M020
C Lip Serum Mineral Broad Spectrum SPF 30SUNSCREENSimply Active Cosmetics323661a6-3602-1ce2-e063-6394a90a8e912025-11-10WarningsExact identifier
application number: M020
buttah Tinted Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEButtah Enterprises, LLC.43458152-0775-dd9c-e063-6394a90a61402025-11-10WarningsExact identifier
application number: M020
Aspen Glow 100% Mineral Broad Spectrum SPF 30 Powder Sunscreen 0.16 oz / 4.6 gZINC OXIDEAspen Glow Cosmetics, LLC142eda44-76e1-7960-e063-6394a90a9ad62025-11-10WarningsExact identifier
application number: M020
TriLipiderm Broad Spectrum SPF 30BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENETriLipid Research Institute, LLC617fc696-c2a1-4855-bafb-0454e64971012025-11-10WarningsExact identifier
application number: M020
TriLipiderm Protective DayHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENETriLipid Research Institute, LLC66726c2b-27e9-5dd1-e053-2991aa0a1ba72025-11-10WarningsExact identifier
application number: M020
Eucerin Sensitive Mineral SPF 50 SunscreenZINC OXIDEBeiersdorf Inccdb25154-e4e3-efc7-e053-2a95a90a2df62025-11-10WarningsExact identifier
application number: M020
ESSENCE BY CATHERINE HINDS Broad Spectrum MINERAL PROTECTION SPF 50ZINC OXIDECatherine Hinds Company, Inc.956e6643-51c9-49c4-bd68-f5ee1b0ae4e02025-11-10WarningsExact identifier
application number: M020
GoodSense SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inc.c85d59a1-6ae1-bb2e-e053-2995a90af20e2025-11-09WarningsExact identifier
application number: M020
GoodSense SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%Geiss, Destin, & Dunn, Inc.c85c5d2b-35f6-2fd5-e053-2995a90a4a532025-11-09WarningsExact identifier
application number: M020
Walgreens SPF 50 Tinted Mineral FluidTITANIUM DIOXIDEWalgreens345918e3-95f8-404c-e063-6394a90a3fca2025-11-09WarningsExact identifier
application number: M020
Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 SunscreenAVOBENZONE, OXYBENZONE, OCTISALATE, OCTINOXATEDistribuidora Comercial Jafra, S.A. de C.V.ad6646c7-c6aa-4610-a0c7-ddd1ddd13cde2025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.d690d5d1-e1fa-404f-a17e-7b97be17b44a2025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.2fbdeff7-4880-49ef-bb4d-e033d18e04592025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.6a86e5fd-6736-45e0-aa7d-d268fdaed4f82025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.42a3625f-5c58-4ec5-895f-b14f744282712025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8e14fe81-cf7f-4a81-afec-e6c8466179c92025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.7dd9f4cb-78d8-4edc-a63c-d4a02930a0f82025-11-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-613-3463354061334170 g in 1 CAN (63354-613-34) 170 g2023-10-31NoNoCurrent