Home NDC 84878-997 Sunsolve MD Balance and Clear
Product NDC 84878-997
11-digit product format 848780997
Labeler code 84878
Product ID 84878-997_4391dc55-23cc-abf7-e063-6394a90a9c21
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Sunsolve MD Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-06
Substance ZINC OXIDE
Active strength 132 mg/mL
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 Sunsolve MD Balance and Clear
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 132 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84878-997-01 Sunsolve MD Balance and Clear 48 mL in 1 BOTTLE, PUMP LOTION 48 4 84878-997-02 Sunsolve MD Balance and Clear 1 in 1 CARTON LOTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84878-997 SUNSOLVE MD BALANCE AND CLEAR (ZINC OXIDE) LOTION [SUNSOLVE MD INC] 2 Current NDC, 2 package rows 20250507_26f3595d-adef-a8a5-e063-6394a90adfd4.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 84878-997-01 84878099701 48 mL in 1 BOTTLE, PUMP 48 ml Historical 84878-997-02 84878099702 1 BOTTLE, PUMP in 1 CARTON (84878-997-02) / 48 mL in 1 BOTTLE, PUMP (84878-997-01) 2024-11-06 No No Current