Home NDC 83103-1819 Ciele Tint and Protect
Product NDC 83103-1819
11-digit product format 831031819
Labeler code 83103
Product ID 83103-1819_58ca6d15-0b7d-8c01-e063-6394a90a3d09
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Ciele
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-02
Substance ZINC OXIDE
Active strength 132 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Ciele Tint and Protect
Listing expiration 2027-12-31 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83103-1819-1 Ciele Tint and Protect 38 mL in 1 BOTTLE LOTION 38 4 83103-1819-2 Ciele Tint and Protect 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 83103-1819 CIELE TINT AND PROTECT (ZINC OXIDE) LOTION [CIELE] 2 Current NDC, 2 package rows 20241010_0162d9c9-07fa-9210-e063-6294a90aa687.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 83103-1819-1 83103181901 38 mL in 1 BOTTLE 38 ml Historical 83103-1819-2 83103181902 1 BOTTLE in 1 CARTON (83103-1819-2) / 38 mL in 1 BOTTLE (83103-1819-1) 1 bottle 2023-06-02 No No Current 83103-1819-4 83103181904 1 BOTTLE, DROPPER in 1 CARTON (83103-1819-4) / 5 mL in 1 BOTTLE, DROPPER (83103-1819-3) 2026-08-03 No No Current