FDA.reportPublic FDA data

HAWAIIAN TROPIC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:29:35

Label at a glance#

ProductHAWAIIAN TROPIC
Active ingredientHOMOSALATE, 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 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 two 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: • ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.2%, Homosalate 7.0%, Octocrylene 4.2% .

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

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 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 two 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

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

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(R)
SUNSCREEN LOTION
SHEER TOUCH
LEAVES SKIN RADIANT
ISLAND BOTANICALS
30
DERM TESTED | VEGAN
BROAD SPECTRUM SPF 30 UVA/UVB
WATER RESISTANT (80 MINUTES)
8 FL. OZ (236 mL)

8 oz8 oz

HAWAIIAN
TROPIC(R)
SUNSCREEN LOTION
SHEER TOUCH
LEAVES SKIN RADIANT
ISLAND BOTANICALS
30
VEGAN
BROAD SPECTRUM SPF 30 UVA/UVB
2 FL. OZ (59 mL)

Front LabelFront Label

back label - top panelback label - top panel

back label - 2nd panelback label - 2nd panel

back label - bottom panelback label - bottom panel

HAWAIIAN
TROPIC(R)
SUNSCREEN LOTION
SHEER TOUCH
LEAVES SKIN RADIANT
ISLAND BOTANICALS
30
DERM TESTED | VEGAN
BROAD SPECTRUM SPF 30 UVA/UVB
WATER RESISTANT (80 MINUTES)
10.8 FL. OZ (319 mL)

FULL LABELFULL LABEL

2 PACK

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

30

VEGAN | DERM TESTED

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

2-8 FL. OZ (236 mL) BOTTLES - TOTAL 16 FL. OZ. (472 mL)

Front and Back LabelFront and Back Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130075486088446GTIN-13: 0075486088446
EAN-13: 0075486088446
GTIN-12: 075486088446
UPC-A: 075486088446
GTIN storage (14 digits): 00075486088446		63354-491-11 - Back Label1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-912-11HAWAIIAN TROPIC59 g in 1 BOTTLELOTION598
63354-912-16HAWAIIAN TROPIC236 g in 1 BOTTLELOTION2368
63354-912-17HAWAIIAN TROPIC319 g in 1 BOTTLELOTION3198
63354-912-19HAWAIIAN TROPIC236 g in 1 BOTTLELOTION2368

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
63354-91263354-912-11, 63354-912-16, 63354-912-17, 63354-912-19

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
GLYCERINPDC6A3C0OXIACT
COCO GLUCOSIDEICS790225BIACT
SHEA BUTTERK49155WL9YIACT
MANGOI629I3NR86IACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MICAV8A1AW0880IACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
SODIUM HYDROXIDE55X04QC32IIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLORPHENESINI670DAL4SZIACT
XANTHAN GUMTTV12P4NEEIACT
PAPAYAKU94FIY6JBIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
EDETATE DISODIUM7FLD91C86KIACT
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
BENZYL ALCOHOLLKG8494WBHIACT
PANTHENOLWV9CM0O67ZIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
ALOE VERA LEAFZY81Z83H0XIACT
GUAVA74O70D6VG0IACT
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-11-06monthly-update2026-06-03 17:39:22
62025-07-10full-release2026-06-01 01:06:53

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,OCTOCRYLENEEdgewell Personal Care Brands LLC05b7aa44-cf8f-d77a-e063-6394a90a850b2025-12-30WarningsExact identifier
ndc (package): 63354-912-11
ndc (package): 63354-912-16
ndc (package): 63354-912-19
ndc (package): 63354-912-17
ndc (product): 63354-912
ndc11 (package): 63354091219
ndc11 (package): 63354091211
ndc11 (package): 63354091216
ndc11 (package): 63354091217
spl id: 4738a85d-2402-8da9-e063-6294a90a6917
spl set id: 05b7aa44-cf8f-d77a-e063-6394a90a850b

Reported adverse events (FAERS/openFDA)#

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