Home NDC 10637-3201 NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE
Product NDC 10637-3201
11-digit product format 106373201
Labeler code 10637
Product ID 10637-3201_350ccba5-c537-588f-e063-6294a90a4f5c
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM
Dosage form LIPSTICK
Route TOPICAL
Labeler Port Jervis Laboratories, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-26
Substance OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE
Active strength 4.5; 7; 3; 9 g/100g; g/100g; g/100g; g/100g
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 NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE
Brand name suffix SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 4.5 g/100g HOMOSALATE 7 g/100g AVOBENZONE 3 g/100g OCTOCRYLENE 9 g/100g
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10637-3201-1 NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZESPF 30 4.8 g in 1 CYLINDER LIPSTICK 4.8 1 10637-3201-2 NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZESPF 30 1 in 1 CARTON LIPSTICK 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10637-3201 NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM) LIPSTICK [PORT JERVIS LABORATORIES, INC.] 1 Current NDC, 2 package rows 20250527_350cd329-8fe2-314f-e063-6394a90ac954.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 10637-3201-1 10637320101 4.8 g in 1 CYLINDER 4.8 g Historical 10637-3201-2 10637320102 1 CYLINDER in 1 CARTON (10637-3201-2) / 4.8 g in 1 CYLINDER (10637-3201-1) 1 cylinder 2025-05-26 No No Current