FDA.reportPublic FDA data

Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 30

Product NDC
63354-470
Requested package NDC
63354-470-17
11-digit product format
633540470
Labeler code
63354
Product ID
63354-470_e429484f-0c17-3a8e-e053-2995a90a9f17
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-26
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63354-47063354-470-17DDiscontinued by firm2026-11-06

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-470-16Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 30227 g in 1 BOTTLELOTION2274
63354-470-17Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 30284 g in 1 BOTTLELOTION2844
63354-470-21Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 3028.3 g in 1 TUBELOTION28.34
63354-470-22Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 3085 g in 1 TUBELOTION854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-470BANANA BOAT ULTRA SPORT SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]3Legacy NDC, 4 package rows20231110_a8ea16dc-055a-43e9-e053-2a95a90a33c5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-470-1763354047017284 g in 1 BOTTLE (63354-470-17) 284 g2020-06-260000-00-00NoNoCurrent