HAWAIIAN TROPIC

Product NDC
63354-611
11-digit product format
633540611
Labeler code
63354
Product ID
63354-611_3fe83767-3861-b205-e063-6394a90a38eb
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 9; 4.5; 6.5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HAWAIIAN TROPIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
HOMOSALATE9 g/100g
OCTISALATE4.5 g/100g
OCTOCRYLENE6.5 g/100g

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-611-22HAWAIIAN TROPIC74 g in 1 TUBELOTION742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-611HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]1Current NDC, 1 package rows20241001_203c82a2-0131-8023-e063-6294a90aba7b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-611-226335406112274 g in 1 TUBE (63354-611-22) 74 g2024-10-01NoNoHistorical