FDA.reportPublic FDA data

HAWAIIAN TROPIC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2025-09-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:15:03

Label at a glance#

ProductHAWAIIAN TROPIC
Active ingredientOCTOCRYLENE, HOMOSALATE, AVOBENZONE, OCTISALATE
Label structure9 sections

Indications and uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

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 • Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: • ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen Agent

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

this product 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 • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • 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, Silica, Propylene Glycol, Cetyl Dimethicone, Phenoxyethanol, Mica, Sodium Polyacrylate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Fragrance, Chlorphenesin, Glycerin, Disodium EDTA, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Hibiscus Sabdariffa Flower Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Titanium Dioxide.

Questions or Comments?

OTC - QUESTIONS SECTION

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

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN
TROPIC
SUNSCREEN LOTION
SHEER TOUCH
FACE
LEAVES SKIN RADIANT
HYALURONIC ACID
60+
DERM TESTED | VEGAN
BROAD SPECTRUM SPF 60+
2.5 FL. OZ (74 mL)

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-611-22HAWAIIAN TROPIC74 g in 1 TUBELOTION742

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-61163354-611-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
CHLORPHENESINI670DAL4SZIACT
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
MICAV8A1AW0880IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
MANGOI629I3NR86IACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
GUAVA74O70D6VG0IACT
EDETATE DISODIUM7FLD91C86KIACT
PAPAYAKU94FIY6JBIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
HYALURONATE SODIUMYSE9PPT4THIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CAPRYLYL GLYCOL00YIU5438UIACT

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,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c82a2-0131-8023-e063-6294a90aba7b2025-09-28WarningsExact identifier
ndc (package): 63354-611-22
ndc (product): 63354-611
ndc11 (package): 63354061122
spl id: 3fe83767-3861-b205-e063-6394a90a38eb
spl set id: 203c82a2-0131-8023-e063-6294a90aba7b

Reported adverse events (FAERS/openFDA)#

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