FDA.reportPublic FDA data

Hawaiian Tropic Silk Hydration Broad Spectrum SPF 15

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 20:50:42

Label at a glance#

ProductHawaiian Tropic Silk Hydration Broad Spectrum SPF 15
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE
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 of 15 or higher and other sun protection measures including: • limit ti...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1.5%, Homosalate 5.0%, Octocrylene 3.5%

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.

May stain some fabrics.

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.

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 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 Ingedients

INACTIVE INGREDIENT SECTION

Alcohol Denat., Isododecane, Diisopropyl Adipate, Mineral Oil, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Lauryl PEG-8 Dimethicone, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Argania Spinosa Kernel Oil, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Olea Europaea (Olive) Fruit Oil, Water, Panthenol, 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 UV RAY, Mon-Fri

Primary Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN

Tropic (R)

Silk

HYDRATION (R)

Dry Oil Sunscreen

WEIGHTLESS OIL

15

BROAD SPECTRUM SPF 15 UVA/UVB

Coconut & Argan Oil

Non-greasy

Reef Friendly*

5 FL. OZ. (148 mL)

63354-311-1363354-311-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-311HAWAIIAN TROPIC SILK HYDRATION BROAD SPECTRUM SPF 15 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]4Legacy NDC20241102_af9c1a1a-c713-4a75-e053-2a95a90a27b2.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-31163354-311-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ASCORBYL PALMITATEQN83US2B0NIACT
COCONUT OILQ9L0O73W7LIACT
GRAPE SEED OIL930MLC8XGGIACT
CAPRYLYL GLYCOL00YIU5438UIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
PANTHENOLWV9CM0O67ZIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
HOMOSALATEV06SV4M95SACTIB
ISODODECANEA8289P68Y2IACT
ALCOHOL3K9958V90MIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
ARGAN OIL4V59G5UW9XIACT
WATER059QF0KO0RIACT
PAPAYAKU94FIY6JBIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
MINERAL OILT5L8T28FGPIACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
MANGOI629I3NR86IACT
GUAVA74O70D6VG0IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
25ccb6a9-4207-165a-e063-6394a90a47fcaf9c1a1a-c713-4a75-e053-2a95a90a27b22024-10-31WarningsExact identifier
spl id: 25ccb6a9-4207-165a-e063-6394a90a47fc
spl set id: af9c1a1a-c713-4a75-e053-2a95a90a27b2

Reported adverse events (FAERS/openFDA)#

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