FDA.reportPublic FDA data

HAWAIIAN TROPIC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2024-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:30:10

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 tim...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

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

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

HAWAIIAN
TROPIC®
SUNSCREEN LOTION
SKIN DEFENSE
PROTECTS AGAINST UVA SKIN AGING
GREEN TEA EXTRACT
50
CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 50 UVA/UVB
WATER RESISTANT (80 MINUTES)
6 FL. OZ (177 mL)

LabelLabel

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
63354-636-24HAWAIIAN TROPIC177 g in 1 TUBELOTION1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-636HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]2Current NDC, 1 package rows20241029_16b4342e-6705-ca09-e063-6294a90a947d.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
63354-63663354-636-24

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
CHLORPHENESINI670DAL4SZIACT
ALOE VERA LEAFZY81Z83H0XIACT
AVOBENZONEG63QQF2NOXACTIB
XANTHAN GUMTTV12P4NEEIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
GLYCERINPDC6A3C0OXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
BENZYL ALCOHOLLKG8494WBHIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PAPAYAKU94FIY6JBIACT
OCTISALATE4X49Y0596WACTIB
MANGOI629I3NR86IACT
GUAVA74O70D6VG0IACT
SODIUM HYDROXIDE55X04QC32IIACT
PANTHENOLWV9CM0O67ZIACT
HOMOSALATEV06SV4M95SACTIB
CETETH-10 PHOSPHATE4E05O5N49GIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
OCTOCRYLENE5A68WGF6WMACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
COCO GLUCOSIDEICS790225BIACT
EDETATE DISODIUM7FLD91C86KIACT

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 LLC16b4342e-6705-ca09-e063-6294a90a947d2024-10-27WarningsExact identifier
ndc (package): 63354-636-24
ndc (product): 63354-636
ndc11 (package): 63354063624
spl id: 25821890-359b-36c5-e063-6294a90a5e6b
spl set id: 16b4342e-6705-ca09-e063-6294a90a947d

Reported adverse events (FAERS/openFDA)#

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