Home NDC 68078-040 Calming Primer SPF 20
Product NDC 68078-040
11-digit product format 680780040
Labeler code 68078
Product ID 68078-040_54f6f676-1299-4c63-b090-fc1bc26b76eb
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form LIQUID
Route TOPICAL
Labeler Colorescience
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 54; 54 mg/mL; 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 Calming Primer SPF 20
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 54 mg/mL ZINC OXIDE 54 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP 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 68078-040-01 Calming Primer SPF 20 30 mL in 1 BOTTLE LIQUID 30 2 68078-040-01 Calming Primer SPF 20 1 in 1 CARTON LIQUID 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68078-040 CALMING PRIMER SPF 20 (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE] 2 Current NDC, Legacy NDC, 2 package rows 20241215_d681cdb5-307e-4a2a-8e1d-2b29131d48d0.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 Marketing end Sample Exclude flag Status 68078-040-01 68078004001 1 BOTTLE in 1 CARTON (68078-040-01) / 30 mL in 1 BOTTLE 1 bottle 2020-01-01 0000-00-00 No No Current