Home NDC 84803-104 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk
Product NDC 84803-104
11-digit product format 848030104
Labeler code 84803
Product ID 84803-104_5a0e9ed0-8900-f1b7-e063-6394a90abe9f
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 OCTINOXATE; AVOBENZONE; OCTOCRYLENE
Active strength 5; 3; 4.7 g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 5 g/100g AVOBENZONE 3 g/100g OCTOCRYLENE 4.7 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup G63QQF2NOX Internal UNII lookup 5A68WGF6WM Internal UNII lookup
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 84803-104-01 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk 7 g in 1 TUBE OINTMENT 7 4 84803-104-02 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk 15 g in 1 TUBE OINTMENT 15 4 84803-104-02 ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit 15 g in 1 TUBE OINTMENT 1 g in 15 3 g in 100g 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84803-104 ULTRA VIOLETTE SHEEN SCREEN BROAD SPECTRUM HYDRATING LIP BALM DUSK (SPF50) OINTMENT [GRACE AND FIRE USA INC.] 2 Current NDC, 2 package rows 20250227_2735ab0f-5eec-04c5-e063-6394a90aa60e.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 162 of 353 · 7,041 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84803-104-01 84803010401 7 g in 1 TUBE (84803-104-01) 7 g 2024-12-01 No No Current 84803-104-02 84803010402 15 g in 1 TUBE (84803-104-02) 15 g 2024-12-01 No No Current