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 6 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 CORBY, JR., TERRY L. 594443fd-8e27-4ec6-e063-6294a90a3ff0 2026-08-17 Warnings Exact identifier application number: M020 Meraki Protective Mist Sunscreen BROAD SPECTRUM SPF 30 MERAKI MEDICAL SPA LLC 59446224-0e97-ae2c-e063-6394a90a2a65 2026-08-17 Warnings Exact identifier application number: M020 Sun Zapper - Acne Pure Zinc Sunscreen SPF50 ZINC OXIDE Veganic SKN Limited 3ee435a5-70fb-0c8a-e063-6394a90a650a 2026-08-16 Warnings Exact identifier application number: M020 Sun Zapper - Anti-ageing pure zinc sunscreen SPF30 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 3f1dc3b2-c289-5996-e063-6394a90ac622 2026-08-16 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID SENSITIVE SUNSCREEN ZINC OXIDE ISNTREE Inc. 58e38665-0bca-fb02-e063-6394a90ad62a 2026-08-13 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70 AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE Kenvue Brands LLC 58d3d390-8b88-a6fe-e063-6394a90a9bf8 2026-08-12 Warnings Exact identifier application number: M020 Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60 AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE Kenvue Brands LLC 58d7a3e3-b7df-43ce-e063-6294a90a729c 2026-08-12 Warnings Exact identifier application number: M020 HEB 50 Marigold Scent Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B. 58dafa24-24d5-aeb4-e063-6394a90a3c25 2026-08-12 Warnings Exact identifier application number: M020 TESALOVA Coconut SPF 30 Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Tesalova Viktoriia PMU LLC 58dbb9f1-cfb3-62ac-e063-6394a90a6106 2026-08-12 Warnings Exact identifier application number: M020 Elta MD Skincare UV Stick Broad Spectrum SPF50 ZINC OXIDE CP Skin Health Group, Inc 58dd81db-46d4-d763-e063-6394a90abb0b 2026-08-12 Warnings Exact identifier application number: M020 Basin Coconut SPF 30 Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Retail Concepts of Minnesota, Inc. 4a8e93a6-dcf9-3687-e063-6394a90a73ac 2026-08-12 Warnings Exact identifier application number: M020 UV Skin Recovery SPF 50 Red Correcting ZINC OXIDE CP Skin Health Group, Inc. 26e63890-d1af-d171-e063-6394a90af828 2026-08-12 Warnings Exact identifier application number: M020 UV Skin Recovery SPF 50 ZINC OXIDE CP Skin Health Group, Inc. 26d2683f-cfd5-50fd-e063-6394a90a7576 2026-08-12 Warnings Exact identifier application number: M020 doTERRA Sun Body MINERAL SUNSCREEN doTERRA International, LLC 58dcc56f-f093-469c-e063-6394a90a6088 2026-08-12 Warnings Exact identifier application number: M020 Sonage Protec Plus SPF 30 Mineral Sunscreen ZINC OXIDE ASA Universal Inc. dba: Sonage d92fc1df-bbeb-592a-e053-2a95a90a6951 2026-08-12 Warnings Exact identifier application number: M020 Colorescience Total Protection Body Shield Glow ZINC OXIDE Colorescience 52e1d987-a4f8-195e-e063-6294a90a5629 2026-08-11 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 DR. SAMRAO'S OFFICE 58b2ca35-11ed-d848-e063-6294a90a5b37 2026-08-11 Warnings Exact identifier application number: M020 Ciele Tint and Protect ZINC OXIDE Ciele 0162d9c9-07fa-9210-e063-6294a90aa687 2026-08-11 Warnings Exact identifier application number: M020 NeoStrata Skin Active Matrix Support SPF 30 AVOBENZONE, OCTINOXATE, AND OCTISALATE NeoStrata Company Inc. 8e4b9c08-b906-4c5f-a243-55838ae28b90 2026-08-10 Warnings Exact identifier application number: M020 Sunscreen for Kids SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE The Kroger Co. 1c7cd904-ffff-48aa-91bd-cc978946b36a 2026-08-10 Warnings, Adverse reactions 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