Home NDC 49825-122 Facescreen
Product NDC 49825-122
11-digit product format 498250122
Labeler code 49825
Product ID 49825-122_b735fb3d-6a7a-412d-a9c4-2577c6bc9470
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene,Oxybenzone
Dosage form LIQUID
Route TOPICAL
Labeler Bioelements
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-03-23
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49825-122-02 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49825-122-02 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49825-122-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49825-122-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49825-122-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49825-122-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49825-122-02 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49825-122-02 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49825-122-02 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49825-122-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49825-122-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49825-122-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 49825-122-02 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 49825-122-02 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 49825-122-02 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 49825-122-02 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 49825-122-02 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 49825-122-02 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 49825-122-02 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 49825-122-02 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 49825-122-02 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 49825-122-02 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49825-122-01 FacescreenSPF 50 68 mL in 1 JAR LIQUID 68 1 49825-122-02 FacescreenSPF 50 1 in 1 CARTON LIQUID 1 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 ANGELICA SINENSIS ROOT INACTIVE INGREDIENT B66F4574UG FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 ASIAN GINSENG INACTIVE INGREDIENT CUQ3A77YXI FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) INACTIVE INGREDIENT 59TL3WG5CO FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 CENTELLA ASIATICA INACTIVE INGREDIENT 7M867G6T1U FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 CHAMOMILE INACTIVE INGREDIENT FGL3685T2X FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 CHLORPHENESIN INACTIVE INGREDIENT I670DAL4SZ FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 RHUS GLABRA BARK INACTIVE INGREDIENT 7XC0E9WP6U FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 STEARETH-2 INACTIVE INGREDIENT V56DFE46J5 FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 STEARETH-21 INACTIVE INGREDIENT 53J3F32P58 FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49825-122 FACESCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE) LIQUID [BIOELEMENTS] 1 Legacy NDC, 2 package rows 20120327_c2bcc305-4c68-4cf2-8bd1-ea1dd5ba1fef.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 49825-122-01 49825012201 68 mL in 1 JAR 68 ml Historical 49825-122-02 49825012202 1 in 1 CARTON Historical