FDA.reportPublic FDA data

HAWAIIAN TROPIC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:11

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 5.0%, 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

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 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

Petrolatum, Theobroma Cacao (Cocoa) Seed Butter, Beeswax, Ozokerite, Polyglyceryl-3 Beeswax, Polydipentene, Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil, Hydrogenated Soybean Oil, Flavor, Synthetic Beeswax, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Stevioside, Tocopherol, Water.

Other Information

SPL UNCLASSIFIED SECTION


•Protect the product in this container from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-NO UV Ray

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

HAWAIIAN

TROPIC

SUNSCREEN

LIP BALM

12 HR MOISTURIZATION

ENRICHED WITH

VITAMIN E &

SHEA BUTTER

WATER

RESISTANT

(80 MINUTES)

30

BROAD SPECTRUM

SPF 30 UVA / UVB

NET WT. 0.35 OZ. (9.9 g)

CARTON LABELCARTON LABEL

HAWAIIAN

TROPIC

SUNSCREEN

LIP BALM

12 HR MOISTURIZATION

ENRICHED WITH

VITAMIN E &

SHEA BUTTER

WATER RESISTANT (80 MINUTES)

30

PINEAPPLE

BROAD SPECTRUM SPF 30 UVA / UVB

NET WT. 0.35 OZ. (9.9 g)

TubeTube

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-804-21HAWAIIAN TROPIC9.9 g in 1 TUBEGEL9.92

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
63354-80463354-804-21

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
SYNTHETIC BEESWAX08MNR5YE2RIACT
CANDELILLA WAXWL0328HX19IACT
STEVIOSIDE0YON5MXJ9PIACT
COCOA BUTTER512OYT1CRRIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
SUNFLOWER OIL3W1JG795YIIACT
SHEA BUTTERK49155WL9YIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
YELLOW WAX2ZA36H0S2VIACT
OCTISALATE4X49Y0596WACTIB
TOCOPHEROLR0ZB2556P8IACT
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
CETYL ALCOHOL936JST6JCNIACT
PETROLATUM4T6H12BN9UIACT
OCTOCRYLENE5A68WGF6WMACTIB
POLYGLYCERYL-3 BEESWAXZ98M8HW9A6IACT
WATER059QF0KO0RIACT
CERESINQ1LS2UJO3AIACT

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 LLC228fab45-e0d2-f219-e063-6294a90a1ef62026-01-05WarningsExact identifier
ndc (package): 63354-804-21
ndc (product): 63354-804
ndc11 (package): 63354080421
spl id: 47a412fd-9496-7241-e063-6394a90ac0db
spl set id: 228fab45-e0d2-f219-e063-6294a90a1ef6

Reported adverse events (FAERS/openFDA)#

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