FDA.reportPublic FDA data

Hawaiian Tropic - Edgewell Personal Care Brands LLC

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-25 01:02:44

Label at a glance#

ProductHawaiian Tropic
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE
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 value of 15 or higher and other sun protection measures including: ■ lim...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 9.0%, 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 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 if

OTC - STOP USE SECTION

■ 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.

Other Information

SPL UNCLASSIFIED SECTION

■ protect this product in this container from excessive heat and direct sun ■ May stain some fabrics and surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Octyldodecanol, Hydroxystearic Acid, Butyloctyl Salicylate, Dibutyl Lauroyl Glutamide, Dibutyl Ethylhexanoyl Glutamide, Silica Cetyl Silylate, Silica Dimethicone Silylate, Stearic Acid, Fragrance, Palmitic Acid, Caprylic/Capric Triglyceride, Synthetic fluorphlogopite, Hibiscus Sabdariffa Seed Oil, Ethylhexyl Palmitate, Silica, Camellia Sinensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Iron Oxides.

Questions?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN
TROPIC®
SUNSCREEN STICK
SHIMMER BALM
HYDRATED RADIANT SKIN
GOES ON CLEAR
50
WON'T CLOG PORES | VEGAN
BROAD SPECTRUM SPF 50 UVA/UVB
NET WT. 0.6 OZ (17 g)

LabelLabel

HAWAIIAN
TROPIC®
SUNSCREEN STICK
SHIMMER BALM
HYDRATED RADIANT SKIN
GOES ON CLEAR
50
WON'T CLOG PORES | VEGAN
BROAD SPECTRUM SPF 50 UVA/UVB
NET WT. 0.6 OZ (17 g)

CartonCarton

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-79163354-791-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
MINERAL OILT5L8T28FGPIACT
OCTYLDODECANOL461N1O614YIACT
HYDROXYSTEARIC ACID933ANU3H2SIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIBUTYL LAUROYL GLUTAMIDE3V7K3IA58XIACT
DIBUTYL ETHYLHEXANOYL GLUTAMIDE0IAF2L30VSIACT
STEARIC ACID4ELV7Z65APIACT
PALMITIC ACID2V16EO95H1IACT
HIBISCUS SABDARIFFA SEED OILG2X0304IX1IACT
ETHYLHEXYL PALMITATE2865993309IACT
FERRIC OXIDE RED1K09F3G675IACT
SILICAETJ7Z6XBU4IACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
MANGIFERA INDICA (MANGO) FRUITI629I3NR86IACT
CARICA PAPAYA (PAPAYA) FRUITKU94FIY6JBIACT
PSIDIUM GUAJAVA FRUIT74O70D6VG0IACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT

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 LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsExact identifier
ndc (package): 63354-791-61
ndc (product): 63354-791
ndc11 (package): 63354079161
spl id: 5991466a-e72a-16b7-e063-6394a90a11ff
spl set id: 5991466a-e729-16b7-e063-6394a90a11ff

Reported adverse events (FAERS/openFDA)#

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