HAWAIIAN TROPIC

Product NDC
63354-894
11-digit product format
633540894
Labeler code
63354
Product ID
63354-894_47bdc2f9-bdbf-fae8-e063-6294a90abf8a
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-26
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2; 5.5; 4.5; 4 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HAWAIIAN TROPIC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2 g/100g
HOMOSALATE5.5 g/100g
OCTISALATE4.5 g/100g
OCTOCRYLENE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-894-31HAWAIIAN TROPIC51 g in 1 CANAEROSOL, SPRAY516
63354-894-34HAWAIIAN TROPIC170 g in 1 CANAEROSOL, SPRAY1706
63354-894-39HAWAIIAN TROPIC170 g in 1 BOTTLEAEROSOL, SPRAY1706

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-894HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) AEROSOL, SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, 3 package rows20241108_088fa3cd-b9b8-d10b-e063-6394a90a7fd6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-894-316335408943151 g in 1 CAN51 gHistorical
63354-894-3463354089434170 g in 1 CAN (63354-894-34) 170 g2023-10-26NoNoHistorical
63354-894-3963354089439170 g in 1 BOTTLE (63354-894-39) 170 g2024-12-01NoNoHistorical