Home NDC 84803-103 Ultra Violette Future Screen Broad Spectrum SPF 50
Product NDC 84803-103
11-digit product format 848030103
Labeler code 84803
Product ID 84803-103_533c65d9-90f8-77af-e063-6394a90aefea
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler Grace and Fire USA Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Substance ZINC OXIDE
Active strength 200 mg/mL
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 Future Screen Broad Spectrum SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84803-103-15 Ultra Violette Future Screen Broad Spectrum SPF 50 15 mL in 1 BOTTLE LOTION 15 4 84803-103-21 Ultra Violette Future Screen Broad Spectrum SPF 50 20 mL in 1 BOTTLE, PUMP LOTION 20 4 84803-103-50 Ultra Violette Future Screen Broad Spectrum SPF 50 50 mL in 1 BOTTLE LOTION 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84803-103 ULTRA VIOLETTE FUTURE SCREEN BROAD SPECTRUM SPF 50 (ZINC OXIDE) LOTION [GRACE AND FIRE USA INC.] 2 Current NDC, 3 package rows 20241202_252fdc91-bbe2-58ec-e063-6294a90a5067.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84803-103-15 84803010315 15 mL in 1 BOTTLE (84803-103-15) 15 ml 2024-12-01 No No Current 84803-103-20 84803010320 20 mL in 1 BOTTLE, PLASTIC (84803-103-20) 20 ml 2024-12-01 No No Current 84803-103-21 84803010321 20 mL in 1 BOTTLE, PUMP 20 ml Historical 84803-103-50 84803010350 50 mL in 1 BOTTLE (84803-103-50) 50 ml 2024-12-01 No No Current