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 185 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ELROEL Pang Pang Sun Cushion Plus ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE MONOGLOT HOLDINGS Inc. 5ffaad65-f0b2-416a-b0a3-b92e880641e4 2025-09-18 Warnings Exact identifier application number: M020 e.l.f. Camo CC Cream SPF 30 Fair 125 C HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE e.l.f. Cosmetics, Inc. 407f9c0d-31c6-f5bb-e063-6394a90a4db4 2025-09-18 Warnings Exact identifier application number: M020 Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 1630feee-7e0d-c6f4-e063-6294a90a7b1c 2025-09-17 Warnings Exact identifier application number: M020 Guise Tinted Drops ZINC OXIDE Donis Men LLC 3f039049-5004-2888-e063-6294a90a5150 2025-09-17 Warnings Exact identifier application number: M020 ONE SIZE ON TIL DAWN ONE SIZE ON TIL DAWN Pogi Beauty LLC 3f05d90b-9274-4d21-e063-6294a90a8485 2025-09-17 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint DP3 ZINC OXIDE PUR Minerals 3f073413-b314-e5da-e063-6394a90a9ab4 2025-09-17 Warnings Exact identifier application number: M020 e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 W HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE e.l.f. Cosmetics, Inc. 3fa7ef54-2c4d-9883-e063-6294a90a8d88 2025-09-17 Warnings Exact identifier application number: M020 CVS SPF 50 Face Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CVS 26a69a47-947a-a478-e063-6394a90aa468 2025-09-16 Warnings Exact identifier application number: M020 SkinSuit TM 3 in 1 Moisturizer SPF 50 ZINC OXIDE Skin Authority LLC 5eb27be9-9e80-4f4a-b193-b918d831555d 2025-09-15 Warnings Exact identifier application number: M020 Sun and Honey Tallow Sunscreen SPF 30 ZINC OXIDE Amara Ventures 3eda8a70-7c9e-e920-e063-6394a90a85a2 2025-09-15 Warnings Exact identifier application number: M020 Klein Tools Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE KLEIN TOOLS, INC. 3edcc26a-d960-3fa8-e063-6394a90ab703 2025-09-15 Warnings Exact identifier application number: M020 Klein Tools Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE KLEIN TOOLS, INC. 3ede5e54-4c9f-02f7-e063-6294a90a9df6 2025-09-15 Warnings Exact identifier application number: M020 I.C. Industrial Sunscreen ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE R & R Lotion, Inc b89d687a-7b36-4643-9817-765d4710ca60 2025-09-15 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 97795f0e-d867-4e17-b7c9-ede08e7df70c 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. 2d05659c-57d2-4faf-ab67-1b8d68945aed 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 37W Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. 5ff2b9e4-a778-4667-8c3c-3561317b374a 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 39N Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. bc4f909f-3e2c-4fd7-a129-3c2fac8259f0 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 40C Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. 2dd9a30a-2cde-44c0-9350-3aeab9f7091b 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Get Your Healthy Glowy Skin Bergamot Glow Primer Blueberry Nutri Tint ZINC OXIDE Dolce & Gabbana Beauty S.R.L e375412e-8685-49a2-b1b0-00ab114e14b7 2025-09-12 Warnings Exact identifier application number: M020 Beach Club Mineral Sunscreen ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE R & R Lotion, Inc d9aae241-229e-4123-abe9-99f74f5ab0b3 2025-09-12 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