HAWAIIAN TROPIC

Product NDC
63354-317
11-digit product format
633540317
Labeler code
63354
Product ID
63354-317_419b8062-17ab-d130-e063-6294a90a6dcf
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE OCTISALATE OCTOCRYLENE
Dosage form
OIL
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-11
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
2; 2.5; 3 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
AVOBENZONE2 g/100g
OCTISALATE2.5 g/100g
OCTOCRYLENE3 g/100g

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-317-16HAWAIIAN TROPIC236 g in 1 BOTTLE, PUMPOIL2361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-317-1663354031716236 g in 1 BOTTLE, PUMP (63354-317-16) 236 g2023-09-11NoNoCurrent