Home NDC 84803-101 Ultra Violette Preen Screen Broad Spectrum SPF 50
Product NDC 84803-101
11-digit product format 848030101
Labeler code 84803
Product ID 84803-101_533cb134-43ee-e843-e063-6294a90a38a1
Type HUMAN OTC DRUG
Nonproprietary name AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form SPRAY
Route TOPICAL
Labeler Grace and Fire USA Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Substance OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength 50; 60; 100; 30 mg/mL; mg/mL; mg/mL; 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 Preen Screen Broad Spectrum SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 50 mg/mL OCTOCRYLENE 60 mg/mL HOMOSALATE 100 mg/mL AVOBENZONE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 84803-101-30 ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit 30 mL in 1 BOTTLE, SPRAY SPRAY 1 mL in 30 30 mg in 1mL 4 84803-101-30 Ultra Violette Preen Screen Broad Spectrum SPF 50 30 mL in 1 BOTTLE, SPRAY SPRAY 30 2 84803-101-50 Ultra Violette Preen Screen Broad Spectrum SPF 50 50 mL in 1 BOTTLE, SPRAY SPRAY 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84803-101 ULTRA VIOLETTE PREEN SCREEN BROAD SPECTRUM SPF 50 (AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) SPRAY [GRACE AND FIRE USA INC.] 1 Current NDC, 2 package rows 20241202_26a0fc0d-a903-2ac1-e063-6394a90a13db.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 196 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Aruba Aloe Balm NV 6a398dad-2fb9-4cdb-86c5-2a392b88f29b 2025-08-13 Warnings Exact identifier application number: M020 SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40 ZINC OXIDE ALL THE RAJE, LLC 9ffbd53b-1295-42b4-9cd5-18cbb75921d0 2025-08-13 Warnings Exact identifier application number: M020 MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, Bistre ZINC OXIDE Power Beauty Co. 2e6eac42-0b70-44ea-e063-6294a90a49f8 2025-08-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE/OCTOCRYLENE/OXYBENZONE Edgewell Personal Care Brands LLC 3c414e9b-6c3e-2c8d-e063-6394a90af4a6 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Baby Mineral Sunscreen SPF 40 ZINC OXIDE Eleeo Brands LLC 3c443347-0134-8c87-e063-6294a90a8046 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Baby Face Mineral Sunscreen Stick SPF 40 ZINC OXIDE Eleeo Brands LLC 3a22f0b9-2d6d-6230-e063-6294a90adf31 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40 ZINC OXIDE Eleeo Brands LLC 3c4567d6-879e-f995-e063-6394a90a319f 2025-08-13 Warnings Exact identifier application number: M020 Silk Screen TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c457455-b9b1-546b-e063-6294a90a41f6 2025-08-13 Warnings Exact identifier application number: M020 Earth Mama Tinted Mineral Sunscreen SPF 40 ZINC OXIDE Eleeo Brands LLC 3c455d29-df4e-f4d5-e063-6394a90a97ba 2025-08-13 Warnings Exact identifier application number: M020 Baby Bum Mineral 50 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3c470ff8-37d6-a729-e063-6294a90aa525 2025-08-13 Warnings Exact identifier application number: M020 Sun Bum 50 Mineral Sunscreen 1 OZ ZINC OXIDE Sun Bum, LLC 3c483d04-8942-5269-e063-6294a90a3881 2025-08-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE/OCTOCRYLENE/OXYBENZONE Edgewell Personal Care Brands LLC 3c49c623-47c6-4dc9-e063-6294a90a0096 2025-08-13 Warnings Exact identifier application number: M020 100% MINERAL SUNSCREEN 100% MINERAL SUNSCREEN Guangzhou Pallas Cosmetics Co.,Ltd. 3c4a3b41-9183-3835-e063-6394a90aea61 2025-08-13 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 FAIR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 4443d4e6-bdc9-4547-9189-e94e9e0bdd2d 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC Red Correct Color Correcting SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L a6cd16cc-5fe3-41b5-b724-83e469cd4d5e 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 BRONZE OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 4aa12cf0-0c48-4b40-9c9a-bd50523cce8a 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 MEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 5bdaa149-47aa-40ac-b17a-ea6d29099862 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1dda967c-2d69-8948-e063-6294a90ad2a4 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 24e9a9b8-41ba-123a-e063-6394a90a73cb 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1dd9fe59-9e40-fd06-e063-6394a90a4ca2 2025-08-12 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84803-101-30 84803010130 30 mL in 1 BOTTLE, SPRAY (84803-101-30) 30 ml 2024-12-01 No No Current 84803-101-50 84803010150 50 mL in 1 BOTTLE, SPRAY (84803-101-50) 50 ml 2024-12-01 No No Current