FDA.reportPublic FDA data

BANANA BOAT

Product NDC
63354-166
11-digit product format
633540166
Labeler code
63354
Product ID
63354-166_26d3bd0d-a9f4-3d23-e063-6394a90a16f3
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
9; 2.7; 7; 4.5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
BANANA BOAT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE9 g/100g
AVOBENZONE2.7 g/100g
OCTOCRYLENE7 g/100g
OCTISALATE4.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
05cb5a91-205f-b652-e063-6294a90a0664Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-166-14BANANA BOAT162 g in 1 BOTTLE, PUMPSPRAY1627
63354-166-17BANANA BOAT324 g in 1 BOTTLE, PUMPSPRAY3247

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-166BANANA BOAT (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]7Current NDC, 2 package rows20241115_05cb5a91-205f-b652-e063-6294a90a0664.zip

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 213 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS351251f5-e656-98b6-e063-6394a90ad8052025-05-14WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS35129e6f-c6bd-a9f7-e063-6394a90ab0e42025-05-14WarningsExact identifier
application number: M020
Noevir Raysela UV Shield PrimerZINC OXIDE, OCTINOXATENippon Shikizai, Inc.45030b2f-21cf-4285-af12-87ea8f0b8df72025-05-14WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEONESKIN INC.351d55f6-fcd9-1d47-e063-6294a90a2cf02025-05-14WarningsExact identifier
application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350cd329-8fe2-314f-e063-6394a90ac9542025-05-13WarningsExact identifier
application number: M020
Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30ZINC OXIDELancer Skincare LLC522a9158-2fd1-4634-adef-2ba84c86bcd72025-05-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENENavajo Manufacturing Company Inc.33f13aa4-9279-c251-e063-6294a90a2d672025-05-12WarningsExact identifier
application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEPZINC OXIDEAllure Labs34f51ff4-541d-2b2e-e063-6394a90a39da2025-05-12WarningsExact identifier
application number: M020
Bright Guard Natural SPF 30ZINC OXIDERenu Laboratories, LLCe7035fcd-6894-3360-e053-2a95a90a6f1d2025-05-12WarningsExact identifier
application number: M020
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEAllure Labs34f674c1-5d59-915a-e063-6394a90a6c2f2025-05-12WarningsExact identifier
application number: M020
Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONEMeaningful Beauty, LLCf59fe019-569b-49ba-accf-fa4d356ce96b2025-05-12WarningsExact identifier
application number: M020
Cicatricure Gold Lift SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGenomma Lab USA34cc5b3c-af36-e202-e063-6294a90a13a72025-05-10WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationfe19a057-a3c6-4c53-92f9-a4a960cd5b082025-05-07WarningsExact identifier
application number: M020
Winter Survival KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDuke Cannon Supply Co.2487ab56-7856-66b0-e063-6394a90a9d872025-05-07WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEAllure Labs3490ed60-60b9-dfcd-e063-6394a90ab17a2025-05-07WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - Nude BeigeZINC OXIDEKoco Life LLC3491084b-348a-f2bf-e063-6394a90abd252025-05-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-166-1463354016614162 g in 1 BOTTLE, PUMP (63354-166-14) 162 g2023-10-01NoNoCurrent
63354-166-1763354016617324 g in 1 BOTTLE, PUMP (63354-166-17) 324 g2024-02-01NoNoCurrent