Home NDC 85315-001 HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN
Product NDC 85315-001
11-digit product format 853150001
Labeler code 85315
Product ID 85315-001_43772221-dada-a279-e063-6394a90a39d1
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler ONEAND CO., LTD.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-14
Substance HOMOSALATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE
Active strength 4.5; 2.5; 1.5; 2.25 g/50mL; g/50mL; g/50mL; g/50mL
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 HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 4.5 g/50mL OCTOCRYLENE 2.5 g/50mL AVOBENZONE 1.5 g/50mL OCTISALATE 2.25 g/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 85315-001-01 HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN 50 mL in 1 TUBE LOTION 50 4 85315-001-02 HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN 1 in 1 PACKAGE LOTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85315-001 HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ONEAND CO., LTD.] 3 Current NDC, 2 package rows 20250327_2dc41560-f4a7-5f0b-e063-6294a90a0630.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 27 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85315-001-01 85315000101 50 mL in 1 TUBE 50 ml Historical 85315-001-02 85315000102 1 TUBE in 1 PACKAGE (85315-001-02) / 50 mL in 1 TUBE (85315-001-01) 1 tube 2025-03-14 No No Current