FDA.reportPublic FDA data

HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDE

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2025-11-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:16:31

Label at a glance#

ProductBanana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUS
Active ingredientOCTOCRYLENE, OCTISALATE, HOMOSALATE, ZINC OXIDE
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 and then apply to face • Do not apply in windy conditions • Use in a well-ventilated area • Reapply: • after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 9.0%, Octisalate 3.0%, 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.

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking.

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 away from face to avoid breathing it • Keep out of eyes. Rinse with water to remove.

Stop use

OTC - STOP USE SECTION

and ask a doctor 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

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 and then apply to face • Do not apply in windy conditions • Use in a well-ventilated area • Reapply: • after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: Ask a doctor

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 value 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric, Triglyceride, Butyloctyl Salicylate, Phenoxyethanol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Sodium Citrate.

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®
baby
mineral
enriched
SUNSCREEN LOTION SPRAY
UVA/UVB PROTECTION BROAD SPECTRUM SPF 50+
50+
PEDIATRICIAN TESTED
Won't Run Into Eyes
Water Resistant
(80 Minutes)
FREE FROM
Oxybenzone
Octinoxate
SHAKE WELL
BEFORE USE
NET WT 5 FL OZ
(147mL)

LabelLabel

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-682-13Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUS147 g in 1 BOTTLE, PLASTICLOTION1474

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-68263354-682-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ISODODECANEA8289P68Y2IACT
HOMOSALATEV06SV4M95SACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUSHOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDEEdgewell Personal Care Brands LLCc780d5cf-8388-42e0-e053-2a95a90a7c042025-11-17WarningsExact identifier
ndc (package): 63354-682-13
ndc (product): 63354-682
ndc11 (package): 63354068213
spl id: 43cd6eea-fea8-889d-e063-6394a90a317f
spl set id: c780d5cf-8388-42e0-e053-2a95a90a7c04

Reported adverse events (FAERS/openFDA)#

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