FDA.reportPublic FDA data

HAWAIIAN TROPIC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2025-03-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:13

Label at a glance#

ProductHAWAIIAN TROPIC
Active ingredientOCTISALATE, HOMOSALATE, 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 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: ■ lim...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.5%, Octocrylene 9.0%

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 aging caused by the sun

Warnings

WARNINGS SECTION

For external use only.

May stain some fabrics.

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 warm water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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 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 the product in this container from excessive heat and direct sun

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Ozokerite, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Diisopropyl Adipate, Cetyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone, PEG‐8, Caprylyl Glycol, Silica, Fragrance, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-NO UV Ray

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN TROPIC

SUNSCREEN STICK

WEIGHTLESS

HYDRATION

12 HOUR MOISTURIZATION

60+

BROAD SPECTRUM SPF 60+ UVA/UVB

SWEAT | WATER RESISTANT (80 MINUTES)

NET WT. 0.5 OZ (14.2 g)

Front LabelFront Label

Back LabelBack Label

NEW

HAWAIIAN

TROPIC

SUNSCREEN STICK

WEIGHTLESS

HYDRATION

12 HOUR MOISTURIZATION

WON'T CLOG

PORES

DERM TESTED

BLENDS ACROSS

SKIN TONES

VEGAN

60+

BROAD SPECTRUM

SPF 60+ UVA/UVB

SWEAT | WATER

RESISTANT

(80 MINUTES)

NET WT. 0.5 OZ (14.2 g)

Front CardFront Card

Back CardBack Card

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-861-61HAWAIIAN TROPIC14.2 g in 1 CARTONSTICK14.21

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-86163354-861-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLYL GLYCOL00YIU5438UIACT
PSIDIUM GUAJAVA FRUIT74O70D6VG0IACT
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
ETHYLHEXYL PALMITATE2865993309IACT
CETYL ALCOHOL936JST6JCNIACT
AVOBENZONEG63QQF2NOXACTIB
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
CARICA PAPAYA (PAPAYA) FRUITKU94FIY6JBIACT
DIMETHICONE92RU3N3Y1OIACT
SILICAETJ7Z6XBU4IACT
MANGIFERA INDICA (MANGO) FRUITI629I3NR86IACT
OCTOCRYLENE5A68WGF6WMACTIB
DIISOPROPYL ADIPATEP7E6YFV72XIACT
PEG-8B697894SGQIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
CERESINQ1LS2UJO3AIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT

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 TROPICHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEEdgewell Personal Care Brands LLC302982a3-e3f9-ef46-e063-6394a90abaf82025-03-12WarningsExact identifier
ndc (package): 63354-861-61
ndc (product): 63354-861
ndc11 (package): 63354086161
spl id: 302982a3-e3fa-ef46-e063-6394a90abaf8
spl set id: 302982a3-e3f9-ef46-e063-6394a90abaf8

Reported adverse events (FAERS/openFDA)#

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