Derma E Sun Defense

Product NDC
54108-0418
11-digit product format
541080418
Labeler code
54108
Product ID
54108-0418_61d20f28-5db0-4155-84f2-10302b84002e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide and Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
derma e
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-30
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
26.4; 195 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Derma E Sun Defense
Brand name suffix
SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE26.4 mg/g
ZINC OXIDE195 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54108-0418-1Derma E Sun DefenseSPF 301 in 1 BOXLOTION11
54108-0418-1Derma E Sun DefenseSPF 30113 g in 1 TUBELOTION1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54108-0418DERMA E SUN DEFENSE SPF 30 (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [DERMA E]1Current NDC, 2 package rows20240713_395b73a4-dae7-49da-9dab-ab622117c8c0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54108-0418-1541080418011 TUBE in 1 BOX (54108-0418-1) / 113 g in 1 TUBE1 tube2022-12-30NoNoHistorical