FDA.reportPublic FDA data

Homosalate,Octisalate,Octocrylene,Zinc Oxide

Manufacturer
Edgewell Personal Care Brands, LLC
Effective date
2022-11-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:46:50

Label at a glance#

ProductBanana Boat simply protect sensitive faces Mineral Enriched Sunscreen Broad Spectrum SPF 50
Active ingredientZINC OXIDE, OCTISALATE, HOMOSALATE, OCTOCRYLENE
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 time...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 9.0%, Octisalate 4.5%, Octocrylene 6.0%, 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), decreases 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

WARNINGS 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

OTHER SAFETY INFORMATION

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, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Glycerin, Polyglyceryl-3 Methylglucose Distearate, VP/Eicosene Copolymer, Phenoxyethanol, Xanthan Gum, Glyceryl Stearate, PEG-100 Stearate, Beeswax Polyhydroxystearic acid, Chlorphenesin, Triethoxycaprylylsilane, Disodium EDTA

Other information

SPL UNCLASSIFIED SECTION

• Protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANANA
BOAT®

simply

protect

sensitive™

faces

MINERAL ENRICHED# SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

25% FEWER INGREDIENTS*

MADE WITHOUT OXYBENZONE & PARABENS

HYPOALLERGENIC

Oil Free - Won't Clog Pores

Water Resistant

(80 Minutes)

3 FL. OZ. (88 mL)

63354-769-2263354-769-22

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-769-222022-11-22C16284748780-1d6a99b39-ec7e-a426-e053-dadaa90af4c297684539-bba7-951a-e053-2a95a90a4bea
63354-769-222022-01-28C16284748780-1d6a99b39-ec7e-a426-e053-dadaa90af4c297684539-bba7-951a-e053-2a95a90a4bea

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-76963354-769-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERYL 1-STEARATE258491E1RZIACT
POLYOXYL 100 STEARATEYD01N1999RIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CHLORPHENESINI670DAL4SZIACT
YELLOW WAX2ZA36H0S2VIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT

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
0aaf5202-7769-385d-e063-6394a90aca9297684539-bba7-951a-e053-2a95a90a4bea2023-11-21WarningsExact identifier
spl set id: 97684539-bba7-951a-e053-2a95a90a4bea

Reported adverse events (FAERS/openFDA)#

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