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 ingredientAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE
Label structure13 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 value of 15 or higher and other sun protection measures including: limit t...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 9%, Octisalate 4%, Octocrylene 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 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 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 Ingredient

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 Information

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

50

SPF 50 BROAD SPECTRUM

UVA & UVB PROTECTION

lightweight

moisturing 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
63354-929-542023-10-20C16284748780-1d6a99b39-9d32-a426-e053-dadaa90af4c277cdd346-d273-ed66-e053-2991aa0ae31d
63354-929-542022-01-28C16284748780-1d6a99b39-9d32-a426-e053-dadaa90af4c277cdd346-d273-ed66-e053-2991aa0ae31d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-929-54Hawaiian Tropic177 g in 1 TUBELOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-929HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, Legacy NDC, 1 package rows20241102_77cdd346-d273-ed66-e053-2991aa0ae31d.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
63354-92963354-929-54

Ingredients#

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

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

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 LLC77cdd346-d273-ed66-e053-2991aa0ae31d2024-10-31WarningsExact identifier
ndc (package): 63354-929-54
ndc (product): 63354-929
ndc11 (package): 63354092954
spl id: 25caf4b2-83a0-4520-e063-6294a90ad222
spl set id: 77cdd346-d273-ed66-e053-2991aa0ae31d

Reported adverse events (FAERS/openFDA)#

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