Home NDC 64760-780 Avene Mineral Sunscreen Face and Body
Product NDC 64760-780
11-digit product format 647600780
Labeler code 64760
Product ID 64760-780_26442e95-2a13-2003-e063-6394a90a3f62
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler Pierre Fabre USA Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-17
Substance ZINC OXIDE
Active strength 120 mg/120mg
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 Avene Mineral Sunscreen Face and Body
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 120 mg/120mg
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 64760-780-01 Avene Mineral Sunscreen Face and Body 120 mg in 1 TUBE LOTION 120 2 64760-780-01 Avene Mineral Sunscreen Face and Body 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 64760-780 AVENE MINERAL SUNSCREEN FACE AND BODY (ZINC OXIDE) LOTION [PIERRE FABRE USA INC.] 2 Current NDC, 2 package rows 20241108_fb5b1e94-bed3-8486-e053-6294a90a3a84.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 64760-780-01 64760078001 1 TUBE in 1 CARTON (64760-780-01) / 120 mg in 1 TUBE 1 tube 2023-06-26 No No Current