FDA.reportPublic FDA data

HAWAIIAN TROPIC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:29:35

Label at a glance#

ProductHAWAIIAN TROPIC
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE
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 and then apply to face. • Do not apply in windy conditions • Use in a well-ventilated area • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours. • Sun Protection Meas...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%, Homosalate 8.0%, Octocrylene 6.0%

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

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.

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 and then apply to face. • Do not apply in windy conditions • Use in a 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Diisopropyl Adipate, Butyloctyl Salicylate, Butylene Glycol, Polyglyceryl-3 Methylglucose Distearate, Oryza Sativa (Rice) Starch, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Chlorphenesin, PEG-100 Stearate, Glyceryl Stearate, Fragrance, Sodium Polyacrylate, Glycerin, Aloe Barbadensis Leaf Juice Powder, Disodium EDTA, Sodium Hyaluronate, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract.

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-NO UV RAY, Mon-Fri

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN TROPIC

WATER SUNSCREEN MIST

WEIGHTLESS

HYDRATION

12 HR MOISTURIZATION

HYALURONIC ACID

30

ALCOHOL FREE

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

5. Fl. OZ (153 ml)

FULL LABELFULL LABEL

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

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-32463354-324-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIISOPROPYL ADIPATEP7E6YFV72XIACT
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATEW19EIO0DBEIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
EDETATE DISODIUM7FLD91C86KIACT
PAPAYAKU94FIY6JBIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GUAVA74O70D6VG0IACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
WATER059QF0KO0RIACT
HOMOSALATEV06SV4M95SACTIB
STARCH, RICE4DGK8B7I3SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-100 STEARATEYD01N1999RIACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MANGOI629I3NR86IACT
GLYCERINPDC6A3C0OXIACT
OCTOCRYLENE5A68WGF6WMACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
AVOBENZONEG63QQF2NOXACTIB

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,OCTOCRYLENEEdgewell Personal Care Brands LLC0439b4b6-2792-3af1-e063-6294a90adcfe2025-12-30WarningsExact identifier
ndc (package): 63354-324-14
ndc (product): 63354-324
ndc11 (package): 63354032414
spl id: 473604f5-44a4-ab9a-e063-6394a90a2632
spl set id: 0439b4b6-2792-3af1-e063-6294a90adcfe

Reported adverse events (FAERS/openFDA)#

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