FDA.reportPublic FDA data

HAWAIIAN TROPIC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2025-09-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:22:27

Label at a glance#

ProductHAWAIIAN TROPIC
Active ingredientAVOBENZONE, OCTISALATE, 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 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: • li...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 5.2%

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 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. • May stain some fabrics and surfaces.

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 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 longsleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Carthamus Tinctorius (Safflower) Seed Oil, Diisopropyl Adipate, Oryza Sativa (Rice) Starch, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol Denat., Phenoxyethanol, Carbomer, Caprylyl Glycol, Sodium Hydroxide, Chlorphenesin, Fragrance, Gluconolactone, Xanthan Gum, Disodium EDTA, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Zea Mays (Corn) Oil, Sodium Ascorbyl Phosphate, Beta-Carotene, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit 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

SUNSCREEN LOTION

WEIGHTLESS

HYDRATION

12HR MOISTURIZATION*

ISLAND BOTANICALS

50

DERM TESYTED

BROAD SPECTRUM SPF 50 UVA/UVB

WATER RESISTANT (80 MINUTES)

6 FL. OZ. (177 mL)

Front LabelFront LabelBack LabelBack 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
63354-512-54HAWAIIAN TROPIC177 g in 1 BOTTLELOTION1774

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-51263354-512-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
CHLORPHENESINI670DAL4SZIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
STARCH, RICE4DGK8B7I3SIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
DEHYDRATED ALCOHOL3K9958V90MIACT
OCTISALATE4X49Y0596WACTIB
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALOE VERA LEAFZY81Z83H0XIACT
GUAVA74O70D6VG0IACT
PAPAYAKU94FIY6JBIACT
GLUCONOLACTONEWQ29KQ9POTIACT
CORN OIL8470G57WFMIACT
OCTOCRYLENE5A68WGF6WMACTIB
EDETATE DISODIUM7FLD91C86KIACT
BETA CAROTENE01YAE03M7JIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SAFFLOWER OIL65UEH262ISIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
SODIUM HYDROXIDE55X04QC32IIACT
PANTHENOLWV9CM0O67ZIACT
MANGOI629I3NR86IACT

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,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC053e76f0-8ca0-645d-e063-6394a90a01d22025-09-28WarningsExact identifier
ndc (package): 63354-512-54
ndc (product): 63354-512
ndc11 (package): 63354051254
spl id: 3fe827b5-1ec2-9507-e063-6294a90a6517
spl set id: 053e76f0-8ca0-645d-e063-6394a90a01d2

Reported adverse events (FAERS/openFDA)#

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