FDA.reportPublic FDA data

HAWAIIAN TROPIC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2025-04-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:59:15

Label at a glance#

ProductHAWAIIAN TROPIC
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE, 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 of 15 or higher and other sun protection measures including: • limit ti...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%, Homosalate 3.5%, Octisalate 2.0%, Octocrylene 4.0%

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 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

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

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

MORE HYDRATING

HAWAIIAN

TROPIC(R)

NON-GREASY SUNSCREEN LOTION

WEIGHTLESS

HYDRATION FACE

12HR MOISTURIZATION

30

CRUELTY FREE / VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

1.7 FL. OZ (50mL)

Front LabelFront Label

Back Label - Top panelBack Label - Top panel

Back Label - 2nd panelBack Label - 2nd panel

Back Label - 3rd panelBack Label - 3rd panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-454-51HAWAIIAN TROPIC50 g in 1 BOTTLELOTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-454HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]4Current NDC, 1 package rows20250418_055431a6-e9e0-99b4-e063-6394a90acb11.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-45463354-454-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
STARCH, RICE4DGK8B7I3SIACT
ALCOHOL3K9958V90MIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
PANTHENOLWV9CM0O67ZIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CORN OIL8470G57WFMIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GUAVA74O70D6VG0IACT
SAFFLOWER OIL65UEH262ISIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
MANGOI629I3NR86IACT
PAPAYAKU94FIY6JBIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
OCTISALATE4X49Y0596WACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CHLORPHENESINI670DAL4SZIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLUCONOLACTONEWQ29KQ9POTIACT
BETA CAROTENE01YAE03M7JIACT

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 LLC055431a6-e9e0-99b4-e063-6394a90acb112025-04-17WarningsExact identifier
ndc (package): 63354-454-51
ndc (product): 63354-454
ndc11 (package): 63354045451
spl id: 32fab56e-9984-9b0e-e063-6394a90aa154
spl set id: 055431a6-e9e0-99b4-e063-6394a90acb11

Reported adverse events (FAERS/openFDA)#

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