Home NDC 49825-114 Bioelements
Product NDC 49825-114
11-digit product format 498250114
Labeler code 49825
Product ID 49825-114_19d7afa4-cd7c-4876-91f7-cf916fa73748
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Bioelements Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2009-01-01
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength 8 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-02 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 49825-114-01 BioelementsSun Diffusing Protector SPF 15 177 mL in 1 BOTTLE CREAM 177 6 49825-114-02 BioelementsSun Diffusing Protector SPF 15 1 in 1 BOX CREAM 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 OCTISALATE ACTIVE MOIETY 4X49Y0596W BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 CITRUS AURANTIUM FLOWER OIL INACTIVE INGREDIENT D4BGE91OXH BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 CITRUS AURANTIUM FRUIT OIL INACTIVE INGREDIENT 59JDQ5VT0T BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 IMIDUREA INACTIVE INGREDIENT M629807ATL BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 LAVENDER OIL INACTIVE INGREDIENT ZBP1YXW0H8 BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 SAGE OIL INACTIVE INGREDIENT U27K0H1H2O BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 SORBITOL INACTIVE INGREDIENT 506T60A25R BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49825-114 BIOELEMENTS SUN DIFFUSING PROTECTOR SPF 15 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOELEMENTS INC.] 6 Legacy NDC, 2 package rows 20120127_6550938a-7299-4e4b-aafe-4d5ce13e79a5.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 49825-114-01 49825011401 177 mL in 1 BOTTLE 177 ml Historical 49825-114-02 49825011402 1 in 1 BOX Historical