Home NDC 69546-313 Sonage Roux Tinted Day Creme with SPF 30
Product NDC 69546-313
11-digit product format 695460313
Labeler code 69546
Product ID 69546-313_29b70a0d-e3eb-db95-e063-6394a90adfb2
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 2023-06-08
Substance ZINC OXIDE
Active strength 13 g/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 Sonage Roux Tinted Day Creme with SPF 30
Brand name suffix Sheer Tinted Moisturizer
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 13 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 69546-313-02 Sonage Roux Tinted Day Creme with SPF 30Sheer Tinted Moisturizer 50 mL in 1 JAR LOTION 50 2 69546-313-02 Sonage Roux Tinted Day Creme with SPF 30Sheer Tinted Moisturizer 1 in 1 CARTON LOTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69546-313 SONAGE ROUX TINTED DAY CREME WITH SPF 30 SHEER TINTED MOISTURIZER (ZINC OXIDE) LOTION [ASA UNIVERSAL INC. DBA: SONAGE] 2 Current NDC, 2 package rows 20241222_fd14d70c-6cd0-5de6-e053-6294a90a7add.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 69546-313-02 69546031302 1 JAR in 1 CARTON (69546-313-02) / 50 mL in 1 JAR 1 jar 2023-06-08 No No Current