Home NDC 64760-783 Avene Hydrance Moisturizing SPF 30
Product NDC 64760-783
11-digit product format 647600783
Labeler code 64760
Product ID 64760-783_1361ebe5-265a-d88f-e063-6294a90a71bb
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 2024-04-01
Substance ZINC OXIDE
Active strength 100 mg/mL
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 Hydrance Moisturizing SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 100 mg/mL
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 64760-783-01 Avene Hydrance Moisturizing SPF 30 1 in 1 CARTON LOTION 1 1 64760-783-01 Avene Hydrance Moisturizing SPF 30 40 mL in 1 TUBE LOTION 40 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64760-783 AVENE HYDRANCE MOISTURIZING SPF 30 (ZINC OXIDE) LOTION [PIERRE FABRE USA INC.] 1 Current NDC, 2 package rows 20240402_1361ebe5-2659-d88f-e063-6294a90a71bb.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 64760-783-01 64760078301 1 TUBE in 1 CARTON (64760-783-01) / 40 mL in 1 TUBE 1 tube 2024-04-01 No No Current