FDA.reportPublic FDA data

Hawaiian Tropic - Edgewell Personal Care Brands, LLC

Manufacturer
Edgewell Personal Care Brands, LLC
Effective date
2026-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-20 03:03:43

Label at a glance#

ProductHawaiian Tropic
Active ingredientOCTISALATE, AVOBENZONE
Label structure9 sections

Indications and uses

￭ helps prevent sunburn

Dosage and administration

￭ apply liberally 15 minutes before sun exposure ￭ reapply: ￭ after 80 minutes of swimming or sweating ￭ immediately after towel drying ￭ at least every two hours ￭ children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 0.50%, Octisalate 4.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

￭ helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. ￭ For external use only ￭ May stain some fabrics and surfaces

￭ Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

￭ When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

￭ Stop and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

￭ Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

￭ apply liberally 15 minutes before sun exposure ￭ reapply: ￭ after 80 minutes of swimming or sweating ￭ immediately after towel drying ￭ at least every two hours ￭ children under 6 months: Ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

￭ protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Diisopropyl Adipate, Myristyl Lactate, Cocos Nucifera (Coconut) Oil, Fragrance, Myristyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-NO UV RAY, Mon-Fri

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN
TROPIC
SUNSCREEN OIL SPRAY
ISLAND
TANNING
ENHANCE TAN & MOISTURIZE
COCONUT OIL
5
DERM TESTED | VEGAN
WATER RESISTANT (80 MINUTES)
SPF 5 UVB
8 FL. OZ. (236 mL)

Front LabelFront Label

Back LabelBack Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-69363354-693-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
MINERAL OILT5L8T28FGPIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
MYRISTYL LACTATE1D822OC34XIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
MYRISTYL ALCOHOLV42034O9PUIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ALOE VERA LEAFZY81Z83H0XIACT
GUAVA74O70D6VG0IACT
PAPAYAKU94FIY6JBIACT
MANGOI629I3NR86IACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT

Source Document#

Source XML

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 1 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsName fallback
brand name: HAWAIIAN TROPIC
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsName fallback
brand name: Hawaiian Tropic
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREENOCTISALATELOreal USA Products Inc3b99ab06-ba4c-4ddd-a057-60028eedd67d2026-06-16WarningsName fallback
generic name: OCTISALATE
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC088fa3cd-b9b8-d10b-e063-6394a90a7fd62026-01-06WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228fab45-e0d2-f219-e063-6294a90a1ef62026-01-05WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228055ec-ff59-4412-e063-6394a90abe142026-01-05WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05ba5966-f0ff-5360-e063-6294a90a0fc92025-12-31WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f4599b-de62-2bc7-e063-6394a90a69ab2025-12-31WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0918fdd3-cffb-78e9-e063-6394a90ad5c72025-12-30WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC090904d1-c04c-3fca-e063-6294a90a7cc72025-12-18WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC0b625d48-9632-0464-e063-6394a90a9adc2025-10-21WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC419b8043-7921-ca77-e063-6394a90a99ba2025-10-20WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC053e76f0-8ca0-645d-e063-6394a90a01d22025-09-28WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0540017a-52ac-7972-e063-6394a90a139c2025-09-28WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f3b27f-b233-d406-e063-6394a90ada762025-09-28WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC128a3772-b9b7-0d10-e063-6294a90a3e052025-09-28WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c82a2-0131-8023-e063-6294a90aba7b2025-09-28WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c780a-3107-d71a-e063-6394a90aca252025-09-28WarningsName fallback
brand name: HAWAIIAN TROPIC
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC31d01fae-4085-d84a-e063-6294a90ab9812025-09-28WarningsName fallback
brand name: HAWAIIAN TROPIC
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC3388c2fa-8082-95d4-e063-6294a90a94b82025-09-28WarningsName fallback
brand name: Hawaiian Tropic

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.