FDA.reportPublic FDA data

Banana Boat Sport Ultra Sunscreen Lip Balm Broad Spectrum SPF 40

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2020-12-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:01:44

Label at a glance#

ProductBanana Boat Sport Ultra Sunscreen Lip Balm Broad Spectrum SPF 40
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, 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 • after eating or drinking • 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 protectio...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

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

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 • after eating or drinking • 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 • children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ozokerite, Caprylic/Capric Triglyceride, Petrolatum, Ethylhexyl Palmitate, Oryza Sativa (Rice) Bran Wax, VP/Eicosene Copolymer, PEG-8. Flavor, Sodium Saccharin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Mineral Oil, 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-SafeSun, Mon-Fri

Primary Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

40

UVA/UVB

PROTECTION

MOISTURIZES

FOR 12 HOURS

Reef Friendly

No Oxybenzone or Octinoxate

BANANA

BOAT (R)

SPORT (tm)

ultra

BROAD SPECTRUM SPF 40

SUNSCREEN LIP BALM

NET WT. 0.15 oz. (4.25 g)

63354-901-6163354-901-61BB WrapBB Wrap

MOISTURIZES

FOR 12 HOURS

REEF FRIENDLY

No Oxybenzone or Octinoxate

40

UVA/UVB

PROTECTION

BANANA

BOAT (R)

SPORT (tm)

ultra

SUNSCREEN LIP BALM

BROAD SPECTRUM SPF 40

NET WT. 0.3 oz. (8.5 g)

63354-901-6263354-901-62

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-901-612024-01-30C16284748780-1d6a99b39-6764-a426-e053-dadaa90af4c2b67403c3-da63-08b4-e053-2995a90a4393
63354-901-622024-01-30C16284748780-1d6a99b39-6764-a426-e053-dadaa90af4c2b67403c3-da63-08b4-e053-2995a90a4393
63354-901-612022-01-28C16284748780-1d6a99b39-6764-a426-e053-dadaa90af4c2b67403c3-da63-08b4-e053-2995a90a4393
63354-901-622022-01-28C16284748780-1d6a99b39-6764-a426-e053-dadaa90af4c2b67403c3-da63-08b4-e053-2995a90a4393

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-90163354-901-61, 63354-901-62

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
COCONUT OILQ9L0O73W7LIACT
ALOE VERA LEAFZY81Z83H0XIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYL PALMITATE2865993309IACT
RICE BRANR60QEP13ICIACT

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
0f2a4d18-04a8-2289-e063-6394a90a3181b67403c3-da63-08b4-e053-2995a90a43932024-01-17WarningsExact identifier
spl set id: b67403c3-da63-08b4-e053-2995a90a4393

Reported adverse events (FAERS/openFDA)#

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