Lip Renewal SPF 50

Product NDC
65278-105
11-digit product format
652780105
Labeler code
65278
Product ID
65278-105_187cd4ad-7820-b0e4-e063-6394a90a414b
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octinoxate, Octisalate
Dosage form
PASTE
Route
TOPICAL
Labeler
June Jacobs Labs, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-12-09
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE
Active strength
.42; 1.4; 1.05; .7 g/14g; g/14g; g/14g; g/14g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lip Renewal SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE.42 g/14g
HOMOSALATE1.4 g/14g
OCTINOXATE1.05 g/14g
OCTISALATE.7 g/14g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65278-105-01Lip Renewal SPF 5014 g in 1 TUBEPASTE141
65278-105-02Lip Renewal SPF 5014 g in 1 CARTONPASTE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65278-105LIP RENEWAL SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) PASTE [JUNE JACOBS LABS, LLC]1Current NDC, 2 package rows20240614_187cd4ad-781f-b0e4-e063-6394a90a414b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65278-105-016527801050114 g in 1 TUBE (65278-105-01) 14 g2012-12-09NoNoHistorical
65278-105-026527801050214 g in 1 CARTON (65278-105-02) 14 g2012-12-09NoNoHistorical