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
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 7; 4.5; 9 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
IngredientStrength
AVOBENZONE3 g/100g
HOMOSALATE7 g/100g
OCTISALATE4.5 g/100g
OCTOCRYLENE9 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10637-3201-1NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZESPF 304.8 g in 1 CYLINDERLIPSTICK4.81
10637-3201-2NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZESPF 301 in 1 CARTONLIPSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10637-3201NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM) LIPSTICK [PORT JERVIS LABORATORIES, INC.]1Current NDC, 2 package rows20250527_350cd329-8fe2-314f-e063-6394a90ac954.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10637-3201-1106373201014.8 g in 1 CYLINDER4.8 gHistorical
10637-3201-2106373201021 CYLINDER in 1 CARTON (10637-3201-2) / 4.8 g in 1 CYLINDER (10637-3201-1) 1 cylinder2025-05-26NoNoHistorical