Home NDC 84197-467 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Ingredient Strength OCTOCRYLENE 100 mg/g ZINC OXIDE 70 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84197-467-00 SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30 50 g in 1 JAR CREAM 50 1 84197-467-00 SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30 1 in 1 BOX CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84197-467 SOLVADERM DERMAXSOL DERMAL DEFENSE MOISTURIZER SPF-30 (OCTOCRYLENE, ZINC OXIDE) CREAM [SOLVADERM LLC] 1 Current NDC, 2 package rows 20240322_0f9a507a-1b72-45f8-a8a8-b7a92a85607f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84197-467-00 84197046700 1 JAR in 1 BOX (84197-467-00) / 50 g in 1 JAR 1 jar 2024-03-04 No No Current