Home NDC 49825-201 SPF 50 Face Sunscreen
Product NDC 49825-201
11-digit product format 498250201
Labeler code 49825
Product ID 49825-201_462ab8c8-dd89-a7d5-e063-6394a90a6c66
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 2026-12-31
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 2026-12-31 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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 129 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Canopy Untinted ZINC OXIDE BORREGO SPRINGS SKINCARE LLC 35824cd5-0036-7886-e063-6394a90ae678 2025-12-12 Exact identifier application number: M020 Canopy SPF 40 Tinted ZINC OXIDE BORREGO SPRINGS SKINCARE LLC 358319c5-ae35-cb3b-e063-6394a90ad77f 2025-12-12 Exact identifier application number: M020 Non-Tinted Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3581ab49-ef55-3743-e063-6394a90a3bd5 2025-12-12 Exact identifier application number: M020 Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3581cf33-3520-42f7-e063-6394a90a6f93 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen For Face and Body ZINC OXIDE Skin Philosophy by Kelly 358248e6-16cf-6f9b-e063-6394a90a55d7 2025-12-12 Exact identifier application number: M020 Replenishing Mineral Sunscreen ZINC OXIDE Skin Philosophy by Kelly 35828e76-66db-49de-e063-6294a90a2b99 2025-12-12 Exact identifier application number: M020 Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3592b2c7-295a-7c60-e063-6394a90a387b 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen For Face and Body ZINC OXIDE Skin Philosophy by Kelly 3592fd5f-13d1-9aec-e063-6394a90abd67 2025-12-12 Exact identifier application number: M020 Replenishing Mineral Sunscreen ZINC OXIDE Skin Philosophy by Kelly 359371f2-2407-e1a1-e063-6294a90a2165 2025-12-12 Exact identifier application number: M020 Non Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 397fc3c9-9d30-adcf-e063-6394a90ac761 2025-12-12 Exact identifier application number: M020 Non Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 39800bf1-e01a-e1c8-e063-6294a90a53bf 2025-12-12 Exact identifier application number: M020 Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 397130ea-dfad-ecd3-e063-6394a90a7da4 2025-12-12 Exact identifier application number: M020 Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 39716532-a699-63b7-e063-6294a90aa0f0 2025-12-12 Exact identifier application number: M020 Sun Elegant Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE SKIN BY NESRIN 3580ae10-1867-cb68-e063-6394a90a72df 2025-12-12 Exact identifier application number: M020 Simply Zinc Mineral Sunscreen Tinted ZINC OXIDE SKIN BY NESRIN 3580da4f-116d-8108-e063-6294a90a7bf4 2025-12-12 Exact identifier application number: M020 PROTECTOR SOLAR NON-TINTED SPF SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE The Beez Kneez Skin Care & Acne Clinic LLC 358195c0-6d28-1ffe-e063-6394a90a6027 2025-12-12 Exact identifier application number: M020 PROTECTOR SOLAR TINTED SPF SUNSCREEN ZINC OXIDE The Beez Kneez Skin Care & Acne Clinic LLC 3581d973-ac0b-7d2e-e063-6294a90ae2b3 2025-12-12 Exact identifier application number: M020 Matte Velvet Tint TITANIUM DIOXIDE, ZINC OXIDE Brent Loftis, D.O., Inc., A California Medical Corporation 3583f860-664b-2658-e063-6394a90a3857 2025-12-12 Exact identifier application number: M020 Satin Tint ZINC OXIDE Brent Loftis, D.O., Inc., A California Medical Corporation 35920108-7f8a-27d4-e063-6294a90a0ef6 2025-12-12 Exact identifier application number: M020 SPF Lip TITANIUM DIOXIDE, ZINC OXIDE Brent Loftis, D.O., Inc., A California Medical Corporation 359297cd-10e2-6ddd-e063-6394a90a4aa0 2025-12-12 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