FDA.reportPublic FDA data

HAWAIIAN TROPIC

Product NDC
63354-324
11-digit product format
633540324
Labeler code
63354
Product ID
63354-324_5de3491e-dff3-5c83-e063-6294a90a283f
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTOCRYLENE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Marketing end
2028-10-01
Substance
HOMOSALATE; OCTOCRYLENE; AVOBENZONE
Active strength
8; 6; 2.7 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
HOMOSALATE8 g/100g
OCTOCRYLENE6 g/100g
AVOBENZONE2.7 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-324-14HAWAIIAN TROPIC153 g in 1 BOTTLESPRAY1534

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-324HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, 1 package rows20231005_0439b4b6-2792-3af1-e063-6294a90adcfe.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 83 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. C. Tuna Lumi Radiance BrighteningOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCadf5621b-7cf0-53b3-e053-2a95a90a80582026-01-09WarningsExact identifier
application number: M020
Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15HOMOSALATE, OCTINOXATEFARMASI US LLC1dbd5e83-2248-4751-88d9-b446ccc3c61e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body SunAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLC27fdbd2b-60de-4906-a176-5c5198d9925b2026-01-09WarningsExact identifier
application number: M020
Skin Metal StealthZINC OXIDESkin Metal47f5d7de-5d32-041a-e063-6394a90ab6f92026-01-09WarningsExact identifier
application number: M020
Salt and Blue Body Sunscreen SPF 30ZINC OXIDE 20%Salt + Blue LLC47f764a0-e9ad-ef66-e063-6394a90a8de52026-01-09WarningsExact identifier
application number: M020
City Sunscreen serum Broad Spectrum SPF 30 SupergoopHOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENESupergoop, LLC61766f7b-512d-45b5-b652-e09975a3d3fc2026-01-09WarningsExact identifier
application number: M020
Defense Refresh (Re)Setting Mist SPF 40AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENESupergoop LLCb95ad8e3-978b-b721-e053-2a95a90a1e542026-01-09WarningsExact identifier
application number: M020
Daily Dose Vitamin C and Broad Spectrum SPF 40 SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLCaed0dd03-1695-a5a9-e053-2995a90acfdc2026-01-09WarningsExact identifier
application number: M020
Hand Screen Broad Spectrum Sunscreen SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENESupergoop, LLC972ebab9-3f2f-6716-e053-2a95a90a5c752026-01-09WarningsExact identifier
application number: M020
Glow Oil Broad Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC972c68e7-b137-34c6-e053-2a95a90a77d62026-01-09WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCee045b64-7a95-4378-8183-e6e556f3b1842026-01-09WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC967d0657-18fc-4e4a-b52d-442df43329f12026-01-09WarningsExact identifier
application number: M020
PLAY SPF 30 Lip Shield CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb0b8b850-bdfe-5563-e053-2995a90a51a72026-01-09WarningsExact identifier
application number: M020
Play SPF 30 Lip Shield StrawberryAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb0a49142-53c3-5b7a-e053-2995a90a581d2026-01-09WarningsExact identifier
application number: M020
Glow Stick Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESupergoop, LLC61e543e3-9ace-6440-e053-2991aa0a96472026-01-09WarningsExact identifier
application number: M020
(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35ZINC OXIDESupergoop, LLCaf5c9801-26ce-5c60-e053-2995a90ab4572026-01-09WarningsExact identifier
application number: M020
(Re) Setting 100% mineral Powder Light Broad Spectrum SPF 35ZINC OXIDESupergoop, LLCaed5a7ef-5cf2-6738-e053-2a95a90aa7f72026-01-09WarningsExact identifier
application number: M020
Play Mineral Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC89088ac5-f1ee-1996-e053-2a95a90a8fdc2026-01-09WarningsExact identifier
application number: M020
(RE) Setting 100% Mineral Powder Medium Broad Spectrum Sunscreen SPF 35ZINC OXIDESupergoop, LLCaf4b0f17-43ec-a176-e053-2a95a90a7ac62026-01-09WarningsExact identifier
application number: M020
(Re) Setting 100% mineral Powder Deep Broad Spectrum SPF 35ZINC OXIDESupergoop, LLCaf4cb85b-1275-2105-e053-2995a90a7e742026-01-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-324-1463354032414153 g in 1 BOTTLE (63354-324-14) 153 g2023-10-012028-10-01NoNoHistorical