FDA.reportPublic FDA data

Hawaiian Tropic Matte Effect Mineral Enriched Sunscreen 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 20:50:40

Label at a glance#

ProductHawaiian Tropic Matte Effect Mineral Enriched Sunscreen SPF 50
Active ingredientOCTOCRYLENE, OCTISALATE, ZINC OXIDE, HOMOSALATE
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decrease 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 time in ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 8.0%, Octisalate 4.5%, Octocrylene 5.7%, Zinc Oxide 7.3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

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
  • 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

Water, Isohexadecane, Cetyl Alcohol, Glycerin, VP/Eicosene Copolymer, PEG-100 Stearate, Glyceryl Stearate, Alcohol Denat., Silica, Phenoxyethanol, Xanthan Gum, Polyhydroxystearic Acid, Fragrance, Chlorphenesin, Triethoxycaprylylsilane, Disodium EDTA, Sea Salt, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit 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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAWAIIAN

Tropic®

Matte

EFFECT

MINERAL ENRICHED SUNSCREEN LOTION SPF 50+

Non-Greasy & Lightweight

50+

SPF 50+ Broad Spectrum

UVA & UVB PROTECTION

RECOMMENDED

SKIN

CANCER

FOUNDATION

DAILY USE

Recommended as an

effective broad spectrum

sunscreen

Reef Friendly*

with naturally sourced

sea minerals

6 FL.OZ. (177 mL)

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-542HAWAIIAN TROPIC MATTE EFFECT MINERAL ENRICHED SUNSCREEN SPF 50 (HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS, LLC]4Legacy NDC20241102_90049ae6-c32f-9a28-e053-2a95a90a80b2.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-54263354-542-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENESINI670DAL4SZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM CHLORIDE451W47IQ8XIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
CETYL ALCOHOL936JST6JCNIACT
ALCOHOL3K9958V90MIACT
MANGOI629I3NR86IACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
ISOHEXADECANE918X1OUF1EIACT
XANTHAN GUMTTV12P4NEEIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ZINC OXIDESOI2LOH54ZACTIB
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
GLYCERYL 1-STEARATE258491E1RZIACT
GLYCERINPDC6A3C0OXIACT
HOMOSALATEV06SV4M95SACTIB
PEG-100 STEARATEYD01N1999RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
GUAVA74O70D6VG0IACT
PAPAYAKU94FIY6JBIACT
WATER059QF0KO0RIACT

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
25cc0794-f8c5-424c-e063-6294a90aef9290049ae6-c32f-9a28-e053-2a95a90a80b22024-10-31WarningsExact identifier
spl id: 25cc0794-f8c5-424c-e063-6294a90aef92
spl set id: 90049ae6-c32f-9a28-e053-2a95a90a80b2

Reported adverse events (FAERS/openFDA)#

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