FDA.reportPublic FDA data

Hawaiian Tropic

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:32:51

Label at a glance#

ProductHawaiian Tropic
Active ingredientOCTOCRYLENE, AVOBENZONE, OCTISALATE, HOMOSALATE
Label structure14 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 time in the s...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 6%, Octisalate 4.5%, Octocrylene 4.5%

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 swallowed, get medical help or contact a Poison Control Center right away.

May stain

SPL UNCLASSIFIED SECTION

some fabrics.

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, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethyl Methacrylate, Polymethylsilsesquioxane, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Sodium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Paraffin, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower
Extract, Psidium Guajava Fruit Extract.

Other Infromation

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-NO UV RAY, Mon-Fri

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN

Tropic(R)

AntiOxidant+

SUNSCREEN LOTION

Helps prevent skin damage

& skin aging from the sun

30

SPF 30 BROAD SPECTRUM

UVA & UVB PROTECTION

light weight

moisturizing formula

with green tea extract

6 FL. OZ (177 mL)

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-927-542023-10-20C16284748780-1d6a99b39-4f1d-a426-e053-dadaa90af4c2767accea-c5b2-32dc-e053-2991aa0a3338
63354-927-542022-01-28C16284748780-1d6a99b39-4f1d-a426-e053-dadaa90af4c2767accea-c5b2-32dc-e053-2991aa0a3338

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-927-54Hawaiian Tropic177 g in 1 TUBELOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-927HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, Legacy NDC, 1 package rows20241102_767accea-c5b2-32dc-e053-2991aa0a3338.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-92763354-927-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
XANTHAN GUMTTV12P4NEEIACT
ALOE VERA LEAFZY81Z83H0XIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARICA PAPAYA WHOLES0U63B0Q51IACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
PHENETHYL BENZOATE0C143929GKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLORPHENESINI670DAL4SZIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PASSIFLORA INCARNATA FLOWERK8F3G29S6ZIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
BENZYL ALCOHOLLKG8494WBHIACT
COCO GLUCOSIDEICS790225BIACT
HOMOSALATEV06SV4M95SACTIB
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
GUAVA74O70D6VG0IACT
MANGOI629I3NR86IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT

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 LLC767accea-c5b2-32dc-e053-2991aa0a33382024-10-31WarningsExact identifier
ndc (package): 63354-927-54
ndc (product): 63354-927
ndc11 (package): 63354092754
spl id: 25cb02c1-09e3-b2bd-e063-6394a90ab03d
spl set id: 767accea-c5b2-32dc-e053-2991aa0a3338

Reported adverse events (FAERS/openFDA)#

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