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
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 229 of 346 · 6,912 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 SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE BELLE MEDICAL LLC 2cdc69d3-2192-7a38-e063-6294a90a257f 2025-01-29 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Boxbar Beauty LLC 2d04c5e7-f3aa-873f-e063-6294a90a33d2 2025-01-29 Warnings Exact identifier application number: M020 SEAWEED BATH CO. Super Sheer Face Serum SPF-50 ZINC OXIDE The Seaweed Bath Co. a45b46f9-681f-4a8d-b561-165b995ccf80 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish Non-Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc62961-dcef-d7db-e063-6394a90a9ebd 2025-01-28 Warnings Exact identifier application number: M020 Every Sun Day Ultra-Sheer Priming Sunscreen Stick AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Have & Be Co., Ltd. 2b53aa68-9c05-1682-e063-6294a90a968c 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish - Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc73c4f-30ea-0a51-e063-6394a90ac9a4 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish - Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc84aba-006b-a78e-e063-6294a90ae040 2025-01-28 Warnings Exact identifier application number: M020 TiZO Mineral Sun Defense SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals Ltd. 2cc8f7ef-eda3-fe71-e063-6394a90a6a9a 2025-01-28 Warnings Exact identifier application number: M020 Baby Diaper Rash Cream ZINC OXIDE doTERRA International, LLC 641465a1-0daf-1bb9-e053-2a91aa0ab25d 2025-01-28 Warnings Exact identifier application number: M020 HydroPeptide S.P.F. Sun Protection Friends TITANIUM DIOXIDE, ZINC OXIDE HydroPeptide LLC f3669a1e-8b75-4e94-a3f0-71dcbc3fa914 2025-01-28 Warnings Exact identifier application number: M020 doTERRA sun Face Daily Moisturizer ZINC OXIDE doTERRA International, LLC f3836517-e3ec-5e9e-e053-2a95a90a7af1 2025-01-28 Warnings Exact identifier application number: M020 doTERRA sun ZINC OXIDE doTERRA International, LLC da5c48d6-1859-983d-e053-2a95a90a4c3e 2025-01-28 Warnings Exact identifier application number: M020 doTERRA sun ZINC OXIDE doTERRA International, LLC dd2fa6a2-2ba8-4333-e053-2a95a90a9790 2025-01-28 Warnings Exact identifier application number: M020 Tri-water sheer mineral sunscreen cushion SPF30 ZINC OXIDE Eden Brands Inc. 2cd22172-78cb-32f3-e063-6394a90a395d 2025-01-28 Warnings Exact identifier application number: M020 SOS Face Guard Broad Spectrum Sunscreen SPF 30 ZINC OXIDE Tower 28 6687006a-bd79-4e1c-a546-0f0b51b29948 2025-01-28 Warnings Exact identifier application number: M020 LBEL CONCENTRE GLOBAL ANTI AGING SERUM CONCEALER SPF 15 EYES FACE ALMENDRA 230 OCTINOXATE, ZINC OXIDE BEL STAR S.A. 2cb1a767-3228-71ea-e063-6294a90ac89e 2025-01-27 Warnings Exact identifier application number: M020 Meijer SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 26f7566e-5a89-21cf-e063-6294a90ac886 2025-01-27 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish Non-Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cb77125-ff77-2060-e063-6294a90ab69f 2025-01-27 Warnings Exact identifier application number: M020 GLOW RECIPE WATERMELON GLOW DEW SHIELD HYDRATING FLUID SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE Aramara Beauty LLC dba Glow Recipe 2cb90666-6517-a02c-e063-6294a90ab062 2025-01-27 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Z&Z Skin Essentials 2cdc48f3-474f-9c06-e063-6294a90afea1 2025-01-27 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