SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30

Product NDC
84197-467
11-digit product format
841970467
Labeler code
84197
Product ID
84197-467_1427e6f9-923d-4285-e063-6294a90a99e5
Type
HUMAN OTC DRUG
Nonproprietary name
OCTOCRYLENE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
SOLVADERM LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-04
Substance
OCTOCRYLENE; ZINC OXIDE
Active strength
100; 70 mg/g; mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE100 mg/g
ZINC OXIDE70 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5A68WGF6WM, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84197-467-00SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-3050 g in 1 JARCREAM501
84197-467-00SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-301 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84197-467SOLVADERM DERMAXSOL DERMAL DEFENSE MOISTURIZER SPF-30 (OCTOCRYLENE, ZINC OXIDE) CREAM [SOLVADERM LLC]1Current NDC, 2 package rows20240322_0f9a507a-1b72-45f8-a8a8-b7a92a85607f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84197-467-00841970467001 JAR in 1 BOX (84197-467-00) / 50 g in 1 JAR1 jar2024-03-04NoNoHistorical