Dermatone SPF 30

Product NDC
54414-048
11-digit product format
544140048
Labeler code
54414
Product ID
54414-048_32e594c6-6baf-91c3-e063-6394a90ae2a1
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Dermatone Labs LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-26
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
1.8; 7; 5 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dermatone SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.8 g/100mL
HOMOSALATE7 g/100mL
OCTOCRYLENE5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 5A68WGF6WM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54414-048-01Dermatone SPF 3089 mL in 1 TUBELOTION899

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54414-048DERMATONE SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [DERMATONE LABS LLC]9Current NDC, 1 package rows20250418_32e5bddf-a0b5-c511-e063-6294a90aaf66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54414-048-015441400480189 mL in 1 TUBE (54414-048-01) 89 ml2022-06-26NoNoCurrent