Home NDC 61197-313 Zinc Oxide
Product NDC 61197-313
11-digit product format 611970313
Labeler code 61197
Product ID 61197-313_37397b96-ef15-9098-e063-6294a90aafc9
Type HUMAN OTC DRUG
Nonproprietary name Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Tan
Dosage form CREAM
Route TOPICAL
Labeler Pacifica Beauty, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-01
Substance ZINC OXIDE
Active strength 20 mg/100mL
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 Zinc Oxide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 mg/100mL
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 61197-313-00 Zinc Oxide 29 mL in 1 BOTTLE, PUMP CREAM 29 1
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 61197-313-00 61197031300 29 mL in 1 BOTTLE, PUMP (61197-313-00) 29 ml 2025-04-01 No No Current