FDA.reportPublic FDA data

Hawaiian Tropic Silk Hydration Clear Sunscreen Broad Spectrum SPF 50

Manufacturer
Edgewell Personal Care Brands, LLC
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:50:41

Label at a glance#

ProductHawaiian Tropic Silk Hydration Clear Sunscreen Broad Spectrum SPF 50
Active ingredientOCTOCRYLENE, OXYBENZONE, HOMOSALATE, OCTISALATE, AVOBENZONE
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

• 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 • Sun Protection Measures ....

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 3.0%, Oxybenzone 4.0%

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

Flammable

OTHER SAFETY INFORMATION

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

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.

May stain: some fabrics

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

• 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 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

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Dimethicone, Fragrance, Mineral Oil, Ascorbyl Palmitate, Tocopheryl Acetate, Panthenol, Water, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract

Other information

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-NO UVRAY, Mon-Fri

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN

Tropic®

Silk

HYDRATION®

CLEAR SPRAY SUNSCREEN

WEIGHTLESS

Feels as if it's barely on

50

BROAD SPECTRUM

SPF 50

12 HOUR

Moisturization*

with UVA & UVB Protection

Fast absorbing

Water resistant

(80 minutes)

NET WT 6 OZ. (170 g)

63354-939-3463354-939-34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-939HAWAIIAN TROPIC SILK HYDRATION CLEAR SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,OXYBENZONE) SPRAY [EDGEWELL PERSONAL CARE BRANDS, LLC]4Legacy NDC20241102_97c9b8e6-cc57-06ff-e053-2a95a90ad85e.zip

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
63354-93963354-939-34

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
MANGOI629I3NR86IACT
PAPAYAKU94FIY6JBIACT
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
ISODODECANEA8289P68Y2IACT
CAPRYLYL GLYCOL00YIU5438UIACT
HOMOSALATEV06SV4M95SACTIB
ALCOHOL3K9958V90MIACT
DECAMETHYLTETRASILOXANEC23WAL597TIACT
ASCORBYL PALMITATEQN83US2B0NIACT
ALOE VERA LEAFZY81Z83H0XIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
OCTISALATE4X49Y0596WACTIB
MINERAL OILT5L8T28FGPIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
PANTHENOLWV9CM0O67ZIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
ISOBUTANEBXR49TP611IACT
AVOBENZONEG63QQF2NOXACTIB
GUAVA74O70D6VG0IACT

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
25cc1d66-34b2-d767-e063-6294a90ac44697c9b8e6-cc57-06ff-e053-2a95a90ad85e2024-10-31WarningsExact identifier
spl id: 25cc1d66-34b2-d767-e063-6294a90ac446
spl set id: 97c9b8e6-cc57-06ff-e053-2a95a90ad85e

Reported adverse events (FAERS/openFDA)#

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