Home NDC 49825-201 SPF 50 Face Sunscreen
Product NDC 49825-201
11-digit product format 498250201
Labeler code 49825
Product ID 49825-201_5ed59160-c864-4991-e063-6294a90aedc5
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
Dosage form CREAM
Route TOPICAL
Labeler Bioelements, Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-04
Substance AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 3; 10; 7; 5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49825-201-02 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 49825-201-02 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 49825-201-02 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 49825-201-02 1332a3947898…d4bfe170f9cd…
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 SPF 50 Face Sunscreen
Brand name suffix Bioelements
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100mL HOMOSALATE 10 g/100mL OCTINOXATE 7 g/100mL OCTISALATE 5 g/100mL OCTOCRYLENE 5 g/100mL OXYBENZONE 6 g/100mL
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49825-201-01 SPF 50 Face SunscreenBioelements 68 mL in 1 TUBE CREAM 68 5 49825-201-02 SPF 50 Face SunscreenBioelements 1 in 1 BOX CREAM 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49825-201 SPF 50 FACE SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS, INC] 4 Current NDC, Legacy NDC, 2 package rows 20240829_981c7b3c-d7d6-483d-bf32-10d526be5b3f.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 215 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Broad Spectrum SPF45 ZINC OXIDE, OCTINOXATE Drmtlgy, LLC ce93b371-26ab-4493-98e0-98234c3a9ba6 2025-05-01 Warnings Exact identifier application number: M020 Winter Rescue Kit OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE DUKE CANNON SUPPLY CO. 24356548-348d-2cd2-e063-6294a90ab352 2025-04-29 Warnings Exact identifier application number: M020 Prequel Lip Visor SPF 30 CLEAR LIP 30 CLEAR The Center Brands, LLC 33d5d1d4-c516-238c-e063-6294a90ac11c 2025-04-28 Warnings Exact identifier application number: M020 LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BEL STAR SA 33db89ac-2653-78f5-e063-6394a90af03d 2025-04-28 Warnings Exact identifier application number: M020 Lifeguard SUNSCREEN SPHERE 8 INC 32be4eb3-f106-182d-e063-6394a90aa484 2025-04-28 Warnings Exact identifier application number: M020 Practical Alchemy Purify and Protect Duo MICELLAR WATER WIPES AND ZINC OXIDE Over Here, LLC 28514e58-59a6-094a-e063-6394a90a1c7d 2025-04-28 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Porcelain OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 2fbf7f9d-dba7-48f9-b10e-63225e8f1399 2025-04-25 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE Yunqi Cosmetics (Shenzhen) Co., Ltd 3380a271-1538-2e3a-e063-6294a90a90a2 2025-04-24 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE Yunqi Cosmetics (Shenzhen) Co., Ltd 3380f1ac-0320-35f2-e063-6394a90a97eb 2025-04-24 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE 15% Yunqi Cosmetics (Shenzhen) Co., Ltd 33813fe1-8496-d541-e063-6294a90a6254 2025-04-24 Warnings Exact identifier application number: M020 Sunstation Sport Sunscreen SPF 30 OCTISALATE, OCTOCRYLENE, ZINC OXIDE Impact Melanoma Inc ba78aa73-a25b-4a8e-99b2-9262bb9a7d27 2025-04-24 Warnings Exact identifier application number: M020 Olay Age Defying Anti-Wrinkle Day Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE The Procter & Gamble Manufacturing Company 42819c8d-cc0a-4bee-95db-39a69ce7f660 2025-04-24 Warnings Exact identifier application number: M020 LBEL FOREVER MATTE LONGWEAR AND CONTROL FOUNDATION 72H SPF 15 CHAMPAGNE 170N OCTINOXATE, ZINC OXIDE BEL STAR S.A. 338c2c66-497a-f7d1-e063-6294a90a7789 2025-04-24 Warnings Exact identifier application number: M020 The Ordinary UV Filters SPF 45 Serum HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE Deciem 10cde253-26ee-b97d-e063-6394a90a8302 2025-04-23 Warnings Exact identifier application number: M020 BareBack sunscreen SPF50 infused with Hyaluronic acid and vitamin C ZINC OXIDE VeganicSKN 3123aab6-0407-19e5-e063-6394a90a5bd8 2025-04-23 Warnings Exact identifier application number: M020 Sephora Daily Sunscreen Cream Broad Spectrum SPF 30 ZINC OXIDE S+ b49e043b-8164-421c-a02b-3dab0be1454d 2025-04-22 Warnings Exact identifier application number: M020 YAYA Organics SPF-50 Sports Cream ZINC OXIDE YAYA ORGANICS L.L.C. 9eabf1f8-698b-4fa8-98d3-3696c35b044c 2025-04-22 Warnings Exact identifier application number: M020 YAYA Organics SPF-50 Baby Kids Mineral Sunscreen ZINC OXIDE YAYA ORGANICS L.L.C. 3275303d-a448-4fb4-bdce-6442823f8996 2025-04-22 Warnings Exact identifier application number: M020 Oathology Inzincable Sunscreen SPF 50 HOMOSALATE, OCTOCRYLENE, ZINC OXIDE SKINOATH LLC d245dfca-9e32-4e71-9df8-58fff84ef6a9 2025-04-22 Warnings Exact identifier application number: M020 Back9ine Skincare Pure Invisible Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Back 9ine Skincare, LLC 974ede40-cfb5-4612-b168-5d42dd137f63 2025-04-22 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49825-201-01 49825020101 68 mL in 1 TUBE 68 ml Historical 49825-201-02 49825020102 1 TUBE in 1 BOX (49825-201-02) / 68 mL in 1 TUBE (49825-201-01) 1 tube 2016-01-04 0000-00-00 No No Current