Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled

Product NDC
84803-105
11-digit product format
848030105
Labeler code
84803
Product ID
84803-105_47b5b7de-a284-476a-e063-6394a90af2ec
Type
HUMAN OTC DRUG
Nonproprietary name
SPF50
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Grace And Fire USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength
3; 5; 4.7 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
OCTINOXATE5 g/100g
OCTOCRYLENE4.7 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 4Y5P7MUD51, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84803-105-01Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled7 g in 1 TUBEOINTMENT74
84803-105-02Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled15 g in 1 TUBEOINTMENT154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84803-105ULTRA VIOLETTE SHEEN SCREEN BROAD SPECTRUM HYDRATING LIP BALM BEJEWELLED (SPF50) OINTMENT [GRACE AND FIRE USA INC.]2Current NDC, 2 package rows20250227_274a0544-6c71-4d91-e063-6394a90a2247.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84803-105-01848030105017 g in 1 TUBE (84803-105-01) 7 g2024-12-01NoNoHistorical
84803-105-028480301050215 g in 1 TUBE (84803-105-02) 15 g2024-12-01NoNoHistorical