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 01:15:12

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

• Shake well • Hold container 4 to 6 inches from the skin to apply • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands then apply to face. • Do not apply in windy conditions • Use in well-ventilated area • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures. S...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1.5%, Homosalate 3.0%, Octisalate 1.0%, Octocrylene 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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

Flammable: Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 oF. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

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 away from face to avoid breathing it • 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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

DOSAGE & ADMINISTRATION SECTION

• Shake well • Hold container 4 to 6 inches from the skin to apply • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands then apply to face. • Do not apply in windy conditions • Use in well-ventilated area • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 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

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Dimethicone, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Hydroxypropylcellulose, Mineral Oil, Tocopheryl Acetate, Ascorbyl Palmitate, Panthenol, Water, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-NO-UVRAY, Mon-Fri

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN TROPIC®
SUNSCREEN CLEAR SPRAY
WEIGHTLESS
HYDRATION
12HR MOISTURIZATION*
ISLAND BOTANICALS
15
DERM TESTED | VEGAN
BROAD SPECTRUM SPF 15 UVA/UVB
WATER RESISTANT (80 MINUTES)
NET WT 6 OZ (170 g)

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-802-34HAWAIIAN TROPIC170 g in 1 CANAEROSOL, SPRAY1702

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-80263354-802-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISODODECANEA8289P68Y2IACT
MANGOI629I3NR86IACT
OCTOCRYLENE5A68WGF6WMACTIB
ASCORBYL PALMITATEQN83US2B0NIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
GUAVA74O70D6VG0IACT
PAPAYAKU94FIY6JBIACT
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
ALCOHOL3K9958V90MIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
DIMETHICONE92RU3N3Y1OIACT
MINERAL OILT5L8T28FGPIACT
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
ISOBUTANEBXR49TP611IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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 LLC128a3772-b9b7-0d10-e063-6294a90a3e052025-09-28WarningsExact identifier
ndc (package): 63354-802-34
ndc (product): 63354-802
ndc11 (package): 63354080234
spl id: 3fe834a5-1e9e-b099-e063-6394a90a68f3
spl set id: 128a3772-b9b7-0d10-e063-6294a90a3e05

Reported adverse events (FAERS/openFDA)#

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