DERMATONE SPF50 Sunscreen

Product NDC
54414-028
11-digit product format
544140028
Labeler code
54414
Product ID
54414-028_518d22d6-884f-7c55-e063-6294a90a63a8
Type
HUMAN OTC DRUG
Nonproprietary name
Avabenzone 3% Homosalate 10% Octisalate 5%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Dermatone Labs LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-06
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
3; 10; 5 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
DERMATONE SPF50 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
HOMOSALATE10 g/100g
OCTISALATE5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54414-028-05DERMATONE SPF50 Sunscreen141 g in 1 CANSPRAY1412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54414-028-0554414002805141 g in 1 CAN (54414-028-05) 141 g2025-08-06NoNoHistorical