FDA.reportPublic FDA data

Banana Boat

Product NDC
63354-039
11-digit product format
633540039
Labeler code
63354
Product ID
63354-039_42f0fdb5-7ecc-c885-e063-6294a90aff3a
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
2018-10-15
Marketing end
2026-10-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 9; 4.5; 6 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63354-03963354-039-31DDiscontinued by firm2026-08-11
excluded packagepackage63354-03963354-039-37DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0563354-039-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0563354-039-37d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2663354-039-37f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2663354-039-31f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3163354-039-372ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3163354-039-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2863354-039-37a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2863354-039-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2163354-039-37cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2163354-039-31cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1063354-039-37cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1063354-039-31cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3163354-039-37302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3163354-039-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2063354-039-37ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2063354-039-31ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1063354-039-370efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1063354-039-310efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Banana Boat

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE3 g/100g
OCTOCRYLENE9 g/100g
AVOBENZONE4.5 g/100g
HOMOSALATE6 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
76782de6-a542-6f3e-e053-2a91aa0a5afdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-039-31Banana Boat51 g in 1 CANSPRAY516
63354-039-34Banana Boat170 g in 1 CANSPRAY1706
63354-039-37Banana Boat269 g in 1 CANSPRAY2696

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-039BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS, LLC]5Current NDC, Legacy NDC, 3 package rows20241127_76782de6-a542-6f3e-e053-2a91aa0a5afd.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 1 of 360 · 7,197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-06WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC58636012-7e29-7206-e063-6394a90a83e92026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-06WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864275d-a480-06f8-e063-6394a90aecab2026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864881c-c495-1f32-e063-6294a90a13042026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40ZINC OXIDECP Skin Health Group, Inc945538b5-5745-42cf-b610-0018ca2ec2542026-08-06WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC129ae274-0094-be5e-e063-6394a90a98012026-08-05WarningsExact identifier
application number: M020
HERA UV PROTECTOR INVISIBLE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOTCM584c371c-24e3-5f9c-e063-6294a90a01bc2026-08-05WarningsExact identifier
application number: M020
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 IvoryCEILE TINT PROTECT TINTED SERUM SPF 50 IVORYLE COSMETICS INC58547809-3480-1032-e063-6294a90a04c62026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium DeepCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEPLE COSMETICS INC58549160-3594-9056-e063-6394a90abf7d2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 DeepCEILE TINT PROTECT TINTED SERUM SPF 50 DEEPLE COSMETICS INC585498d4-b29c-9580-e063-6394a90adf1e2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 FairCEILE TINT PROTECT TINTED SERUM SPF 50 FAIRLE COSMETICS INC58545633-cb36-6611-e063-6394a90a1f072026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 LightCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHTLE COSMETICS INC5853ae6b-0eaf-e614-e063-6394a90ae91a2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light MediumCEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUMLE COSMETICS INC585473c3-3ee9-7d84-e063-6394a90abd332026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 MediumCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUMLE COSMETICS INC58547b48-251a-10eb-e063-6294a90ac95c2026-08-05WarningsExact identifier
application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium TanCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TANLE COSMETICS INC58547e38-ae84-82ee-e063-6394a90a27d62026-08-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-039-316335400393151 g in 1 CAN (63354-039-31) 51 g2018-10-150000-00-00NoNoCurrent
63354-039-3463354003934170 g in 1 CAN (63354-039-34) 170 g2018-10-152026-10-01NoNoCurrent
63354-039-3763354003937269 g in 1 CAN (63354-039-37) 269 g2018-10-150000-00-00NoNoCurrent