Home NDC 69455-167 Umbra Tinte Mineral Cream SPF 30
Product NDC 69455-167
11-digit product format 694550167
Labeler code 69455
Product ID 69455-167_47b965e1-6106-4d59-e063-6394a90a15f5
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Drunk Elephant, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-11
Substance ZINC OXIDE
Active strength 12 g/60mL
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 Umbra Tinte Mineral Cream SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12 g/60mL
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 69455-167-10 Umbra Tinte Mineral Cream SPF 30 1 in 1 BOX CREAM 1 4 69455-167-10 Umbra Tinte Mineral Cream SPF 30 60 mL in 1 TUBE CREAM 60 4 69455-167-20 Umbra Tinte Mineral Cream SPF 30 1 in 1 TUBE CREAM 1 4 69455-167-20 Umbra Tinte Mineral Cream SPF 30 5 mL in 1 CARTON CREAM 5 4 69455-167-30 Umbra Tinte Mineral Cream SPF 30 2 mL in 1 PACKET CREAM 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69455-167 UMBRA TINTE MINERAL CREAM SPF 30 (ZINC OXIDE) CREAM [DRUNK ELEPHANT, LLC] 3 5 package rows 20250323_6461d19a-16e7-43ac-943c-229fe2c6f76c.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 Status 69455-167-10 69455016710 1 TUBE in 1 BOX (69455-167-10) / 60 mL in 1 TUBE 1 tube 2024-06-11 0 Current 69455-167-20 69455016720 1 CARTON in 1 TUBE (69455-167-20) / 5 mL in 1 CARTON 1 carton 2024-06-11 0 Current 69455-167-30 69455016730 2 mL in 1 PACKET (69455-167-30) 2 ml 2024-06-11 0 Current