FDA.reportPublic FDA data

Hawaiian Tropic

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2019-11-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:57:39

Label at a glance#

ProductHawaiian Tropic
Active ingredientOCTOCRYLENE, OXYBENZONE
Label structure13 sections

Indications and uses

Helps prevent sunburn

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 •Children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 2%, Oxybenzone 4%

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 prevent sunburn not skin cancer or early skin aging

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 product is 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 •Children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ethylhexyl Palmitate, Mineral Oil, Diisopropyl Adipate, Isopropyl Myristate, Silica, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Amyl Acetate, Aloe Barbadensis Leaf Juice, PEG-8 Dimethicone, 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, Octyldodecanol, Retinyl Palmitate, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, 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

HAWAIIAN

Tropic

DARK TANNING

Oil

SPF 6

6

water resistant (80 minutes)

exotic island botanicals

a rare blend of nature's rich oils

indulge Pamper Nourish

63354121166335412116

HAWAIIAN

Tropic®

ISLAND TANNING

Dry Spray Oil

COCONUT OIL

Moisturizes Skin

Enhances Your Tan

6

SPF 6

Water Resistant (80 Minutes)

8 FL. OZ. (236 mL)

63354-121-1663354-121-1663354-121-16 back63354-121-16 back

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-121-162023-12-21C16284748780-1d6a99b39-b97e-a426-e053-dadaa90af4c2480818b5-84ca-4386-e054-00144ff8d46c
63354-121-162022-01-28C16284748780-1d6a99b39-b97e-a426-e053-dadaa90af4c2480818b5-84ca-4386-e054-00144ff8d46c

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-12163354-121-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCOA BUTTER512OYT1CRRIACT
MINERAL OILT5L8T28FGPIACT
AMYL ACETATE92Q24NH7ASIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
MANGIFERA INDICA WHOLEU34MFR958FIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
COCONUT OILQ9L0O73W7LIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARICA PAPAYA WHOLES0U63B0Q51IACT
COLOCASIA ESCULENTA ROOTH7B71Q0G0DIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
PSIDIUM GUAJAVA WHOLE4J570BB45UIACT
OCTYLDODECANOL461N1O614YIACT
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA208G222332IACT
PEG-8 DIMETHICONEGIA7T764ODIACT
ETHYLHEXYL PALMITATE2865993309IACT

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
0d0a2657-4099-3c60-e063-6294a90acabb480818b5-84ca-4386-e054-00144ff8d46c2023-12-21WarningsExact identifier
spl set id: 480818b5-84ca-4386-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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