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
legacy-cache
Hydrated at
2026-08-01 20:51:04

Label at a glance#

ProductHAWAIIAN TROPIC
Active ingredientOCTOCRYLENE, AVOBENZONE
Label structure9 sections

Indications and uses

• Helps prevent sunburn

Dosage and administration

• Shake well • Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands then apply to face. • Do not apply in windy conditions • Use in well-ventilated area • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: A...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Octocrylene 5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• Helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only.


Flammable: Do not puncture or incinerate container. Contents under pressure. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Do not expose to heat or store at temperatures above 120°F.

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 away from face to avoid breathing it • 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 product is swallowed, get medical help or contact a Poison Control Center right away. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

DOSAGE & ADMINISTRATION SECTION

• Shake well • Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands then apply to face. • Do not apply in windy conditions • Use in well-ventilated area • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Ethylhexyl Palmitate, C12-15 Alkyl Benzoate, Isopropyl Myristate, Silica, Cocos Nucifera (Coconut) Oil, Fragrance, Theobroma Cacao (Cocoa) Seed Butter, Amyl Acetate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Water, Panthenol.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN
TROPIC(R)
CLEAR SPRAY SUNSCREEN
ISLAND
TANNING
ENHANCE TAN & MOISTURIZE
COCONUT OIL
12
CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF 12 UVA/UVB
WATER RESISTANT (80 MINUTES)
NET WT 5.5 OZ (158g)

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-805HAWAIIAN TROPIC (AVOBENZONE,OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]2Unmatched20241029_08efc731-104b-12a6-e063-6394a90aca55.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-80563354-805-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
MINERAL OILT5L8T28FGPIACT
MANGOI629I3NR86IACT
COCONUT OILQ9L0O73W7LIACT
COCOA BUTTER512OYT1CRRIACT
ETHYLHEXYL PALMITATE2865993309IACT
OCTOCRYLENE5A68WGF6WMACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PAPAYAKU94FIY6JBIACT
COLOCASIA ESCULENTA ROOTH7B71Q0G0DIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
GUAVA74O70D6VG0IACT
WATER059QF0KO0RIACT
PANTHENOLWV9CM0O67ZIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
AMYL ACETATE92Q24NH7ASIACT
ALOE VERA LEAFZY81Z83H0XIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
AVOBENZONEG63QQF2NOXACTIB

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
25821a7f-3f1b-4659-e063-6394a90a6cea08efc731-104b-12a6-e063-6394a90aca552024-10-27WarningsExact identifier
spl id: 25821a7f-3f1b-4659-e063-6394a90a6cea
spl set id: 08efc731-104b-12a6-e063-6394a90aca55

Reported adverse events (FAERS/openFDA)#

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