Home NDC 84197-967 Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30
Product NDC 84197-967
11-digit product format 841970967
Labeler code 84197
Product ID 84197-967_35b5a241-29c8-3db5-e063-6394a90aec16
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler SOLVADERM LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-19
Substance OCTINOXATE; ZINC OXIDE
Active strength 75; 185 mg/mL; mg/mL
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 Universal Tinted Moisturizer Sunscreen SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 75 mg/mL ZINC OXIDE 185 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 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 84197-967-00 Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30 59 mL in 1 BOTTLE, PUMP LOTION 59 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84197-967 SOLVADERM UNIVERSAL TINTED MOISTURIZER SUNSCREEN SPF 30 (OCTINOXATE, ZINC OXIDE) LOTION [SOLVADERM LLC] 1 Current NDC, 1 package rows 20250529_86dbd8c3-e95a-49a8-afe6-ff9d985e28ba.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 84197-967-00 84197096700 59 mL in 1 BOTTLE, PUMP (84197-967-00) 59 ml 2025-05-19 No No Current