FDA.reportPublic FDA data

HAWAIIAN TROPIC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:36

Label at a glance#

ProductHAWAIIAN TROPIC
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
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: • l...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%, Homosalate 3.0%, Octisalate 2.0%, 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

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 • 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, Cetearyl Alcohol, Phenoxyethanol, Mica, Benzyl Alcohol, Diisopropyl Adipate, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Sodium Hydroxide, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, Titanium Dioxide.

Other Information

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

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

PRICIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN
TROPIC(R)
SUNSCREEN LOTION
SHEER TOUCH
LEAVES SKIN RADIANT
ISLAND BOTANICALS
15
DERM TESTED | VEGAN
BROAD SPECTRUM SPF 15 UVA/UVB
WATER RESISTANT (80 MINUTES)
8 FL. OZ (236 mL)

FULL LABELFULL LABEL

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
63354-494-16HAWAIIAN TROPIC236 g in 1 BOTTLELOTION2362

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-49463354-494-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
WATER059QF0KO0RIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
XANTHAN GUMTTV12P4NEEIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
PAPAYAKU94FIY6JBIACT
MANGOI629I3NR86IACT
GUAVA74O70D6VG0IACT
PANTHENOLWV9CM0O67ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
OCTOCRYLENE5A68WGF6WMACTIB
COCO GLUCOSIDEICS790225BIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CHLORPHENESINI670DAL4SZIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MICAV8A1AW0880IACT
GLYCERINPDC6A3C0OXIACT

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 LLC0918fdd3-cffb-78e9-e063-6394a90ad5c72025-12-30WarningsExact identifier
ndc (package): 63354-494-16
ndc (product): 63354-494
ndc11 (package): 63354049416
spl id: 47366432-4e13-42f0-e063-6394a90a449b
spl set id: 0918fdd3-cffb-78e9-e063-6394a90ad5c7

Reported adverse events (FAERS/openFDA)#

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