Home NDC 69546-322 Sonage Protec Plus SPF 30 Mineral Sunscreen
Product NDC 69546-322
11-digit product format 695460322
Labeler code 69546
Product ID 69546-322_ee78d102-f2aa-4b45-aa66-366819356901
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler ASA Universal Inc. dba: Sonage
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-25
Substance ZINC OXIDE
Active strength 15.7 g/100mL
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 Sonage Protec Plus SPF 30 Mineral Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 15.7 g/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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69546-322-02 Sonage Protec Plus SPF 30 Mineral Sunscreen 50 mL in 1 TUBE LOTION 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69546-322 SONAGE PROTEC PLUS SPF 30 MINERAL SUNSCREEN (ZINC OXIDE) LOTION [ASA UNIVERSAL INC. DBA: SONAGE] 2 Current NDC, Legacy NDC, 1 package rows 20241222_d92fc1df-bbeb-592a-e053-2a95a90a6951.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 69546-322-02 69546032202 50 mL in 1 TUBE (69546-322-02) 50 ml 2022-02-25 0000-00-00 No No Current 69546-322-30 69546032230 30 mL in 1 TUBE (69546-322-30) 30 ml 2026-08-17 No No Current