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BANANA BOAT

Approved
Approval ID

3c49c623-47c6-4dc9-e063-6294a90a0096

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Edgewell Personal Care Brands LLC

DUNS: 151179769

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avobenzone/Octocrylene/Oxybenzone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63354-391
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone/Octocrylene/Oxybenzone
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (21)

HYDROGENATED POLYISOBUTENE (450 MW)Inactive
Code: 7YR4ZFS62E
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
AVOBENZONEActive
Quantity: 2.5 g in 100 g
Code: G63QQF2NOX
Classification: ACTIB
MICROCRYSTALLINE WAXInactive
Code: XOF597Q3KY
Classification: IACT
POLYETHYLENEInactive
Code: UG00KM4WR7
Classification: IACT
BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
ISOHEXADECANEInactive
Code: 918X1OUF1E
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
OCTOCRYLENEActive
Quantity: 7.5 g in 100 g
Code: 5A68WGF6WM
Classification: ACTIB
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ALOE BARBADENSIS LEAF POWDERInactive
Code: ZY81Z83H0X
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CHLORPHENESINInactive
Code: I670DAL4SZ
Classification: IACT
OXYBENZONEActive
Quantity: 3.5 g in 100 g
Code: 95OOS7VE0Y
Classification: ACTIB
LAURYL PEG-8 DIMETHICONE (300 CPS)Inactive
Code: ELL2U7K8T8
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/31/2025

PRINICIPAL DISPLAY PANEL

BANANA
BOAT
KIDS
MAX PROTECT & PLAY
SUNSCREEN LOTION
UVA/UVB BROAD SPECTRUM SPF 100
100
PROTECTS
FROM 99%
OF BURNING RAYS
PEDIATRICIAN TESTED
HIGH ENDURANCE VS. WATER
WATER RESISTANT
(80 MINUTES)
4 FL. OZ. (118 mL)

SLEEVE

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/31/2025

Uses

■ helps prevent sunburn ■ if used as directed with other sun protection measures (seeDirections) decreases the risk of skin cancer and early aging caused by the sun.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/31/2025

Other Information

■protect the product in this container from excessive heat and direct sun

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/31/2025

Active Ingredients

Avobenzone 2.5%, Octocrylene 7.5%, Oxybenzone 3.5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/31/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 7/31/2025

Warnings

For external use only.

May stain some fabrics and surfaces.

Do not use

■ on damaged or broken skin.

** When using this product**

■ keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

■ rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/31/2025

Directions

■ 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 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 INGREDIENT SECTION

LOINC: 51727-6Updated: 7/31/2025

Inactive Ingredients:

Water, Hydrogenated Polyisobutene, Lauryl PEG-8 Dimethicone, Butyloctyl Salicylate, Ethylhexyl Palmitate, Dimethicone, Hydrated Silica, Sodium Chloride, Phenoxyethanol, Beeswax, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Isohexadecane, Microcrystalline Wax, Polyethylene, Chlorphenesin, Caprylyl Glycol, Disodium EDTA, Stearoxy Dimethicone, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/31/2025

Questions or comments?

Call 1-800-SafeSun, Mon-Fri

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BANANA BOAT - FDA Drug Approval Details