FDA.reportPublic FDA data

HAWAIIAN TROPIC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2025-08-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:48

Label at a glance#

ProductHAWAIIAN TROPIC
Active ingredientAVOBENZONE, OCTOCRYLENE
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 0.2%, Octocrylene 0.5%

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 help 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 use 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

Water, Petrolatum, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Sodium Polyacrylate, Chlorphenesin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Xanthan Gum, Disodium EDTA, Aloe Barbadensis Leaf Juice, 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 LOTION
ISLAND
TANNING
ENHANCE TAN & MOISTURIZE
COCOA BUTTER
4
DERM TESTED | VEGAN
WATER RESISTANT (80 MINUTES)
SPF 4 UVB
8 FL. OZ (236 mL)

SLEEVESLEEVE

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-972-56HAWAIIAN TROPIC236 g in 1 BOTTLELOTION2361

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-97263354-972-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
CARICA PAPAYA (PAPAYA) FRUITKU94FIY6JBIACT
WATER059QF0KO0RIACT
CETEARYL ALCOHOL2DMT128M1SIACT
AVOBENZONEG63QQF2NOXACTIB
DIISOPROPYL ADIPATEP7E6YFV72XIACT
PEG-100 STEARATEYD01N1999RIACT
BENZYL ALCOHOLLKG8494WBHIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
PSIDIUM GUAJAVA FRUIT74O70D6VG0IACT
XANTHAN GUMTTV12P4NEEIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
CHLORPHENESINI670DAL4SZIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
MANGIFERA INDICA (MANGO) FRUITI629I3NR86IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
GLYCERYL STEARATE230OU9XXE4IACT
GLYCERINPDC6A3C0OXIACT
CETEARETH-20YRC528SWUYIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
PETROLATUM4T6H12BN9UIACT
CETYL ALCOHOL936JST6JCNIACT
EDETATE DISODIUM7FLD91C86KIACT
OCTOCRYLENE5A68WGF6WMACTIB

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE/OCTOCRYLENEEdgewell Personal Care Brands LLC3c936ed0-ab7a-ccec-e063-6294a90afd932025-08-17WarningsExact identifier
ndc (package): 63354-972-56
ndc (product): 63354-972
ndc11 (package): 63354097256
spl id: 3c936ed0-ab7b-ccec-e063-6294a90afd93
spl set id: 3c936ed0-ab7a-ccec-e063-6294a90afd93

Reported adverse events (FAERS/openFDA)#

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