FDA.reportPublic FDA data

Hawaiian Tropic

Manufacturer
Edgewell Personal Care Brands, LLC
Effective date
2022-11-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:47:17

Label at a glance#

ProductHawaiian Tropic
Active ingredientAVOBENZONE, OCTOCRYLENE
Label structure14 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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 and then apply to face. •Do not apply in windy conditions •Use in a 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

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

For external use only.

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.

Do not puncture or incinerate. Contents under pressure. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Do not store at temperature above 120 °F. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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.

May stain

SPL UNCLASSIFIED SECTION

some fabrics

Directions

DOSAGE & ADMINISTRATION SECTION

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 and then apply to face. •Do not apply in windy conditions •Use in a 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, 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, Panthenol, Water, Fragrance.

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

Front label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HT Dry Oil Spray SPF12 8ozHT Dry Oil Spray SPF12 8ozHT Dry Oil Spray SPF12 6ozHT Dry Oil Spray SPF12 6ozHAWAIIAN

Tropic

Dry Oil

Clear Spray Sunscreen

Broad Spectrum

SPF 12

12

Water Resistant (80 minutes)

skin-nourishing formula

exotic island botanicals

Protect * Pamper * Nourish

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
63354-87563354-875-34, 63354-875-36

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
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
MINERAL OILT5L8T28FGPIACT
ETHYLHEXYL PALMITATE2865993309IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
HYDRATED SILICAY6O7T4G8P9IACT
COCOS NUCIFERA WHOLE245J88W96LIACT
THEOBROMA CACAO WHOLEEB048G1S9JIACT
AMYL ACETATE92Q24NH7ASIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
MANGIFERA INDICA WHOLEU34MFR958FIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
PSIDIUM GUAJAVA WHOLE4J570BB45UIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT
CARICA PAPAYA WHOLES0U63B0Q51IACT
COLOCASIA ESCULENTA ROOTH7B71Q0G0DIACT

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
090a0b09-997e-53dc-e063-6394a90ab6133800ce6c-e0ce-3c01-e054-00144ff8d46c2023-10-31WarningsExact identifier
spl set id: 3800ce6c-e0ce-3c01-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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