Home NDC 83395-050 Vaihea Protect Clean SPF Drops
Product NDC 83395-050
11-digit product format 833950050
Labeler code 83395
Product ID 83395-050_42f4881e-6356-9a8a-e063-6294a90af435
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Vaihea Skincare LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-31
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 Vaihea Protect Clean SPF Drops
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 83395-050-01 Vaihea Protect Clean SPF Drops 50 mL in 1 BOTTLE, DROPPER LOTION 50 4 83395-050-02 Vaihea Protect Clean SPF Drops 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 83395-050 VAIHEA PROTECT CLEAN SPF DROPS (ZINC OXIDE) LOTION [VAIHEA SKINCARE LLC] 2 Current NDC, 2 package rows 20241027_fe7e3145-a8e2-d14f-e053-6394a90abb5e.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 83395-050-01 83395005001 50 mL in 1 BOTTLE, DROPPER 50 ml Historical 83395-050-02 83395005002 1 BOTTLE, DROPPER in 1 CARTON (83395-050-02) / 50 mL in 1 BOTTLE, DROPPER (83395-050-01) 2023-08-31 No No Current