Home NDC 53863-120 Sunscreen Creme SPF 37
Product NDC 53863-120
11-digit product format 538630120
Labeler code 53863
Product ID 53863-120_dd2e2774-4545-43e7-a423-4c53b97fdfbd
Type HUMAN OTC DRUG
Nonproprietary name Octocrylene,Octinoxate,Octisalate,Oxybenzone,Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Exelencia Importers Corp
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-10-15
Marketing end 0000-00-00
Substance OCTOCRYLENE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE
Active strength 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag E
Listing certified through 2017-12-31
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 Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53863-120-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53863-120-02 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53863-120-02 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53863-120-02 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53863-120-02 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53863-120-02 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53863-120-02 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53863-120-02 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53863-120-02 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53863-120-02 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53863-120-02 367a005e9d99…383a685ebd0f…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 53863-120-02 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 53863-120-02 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 53863-120-02 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 53863-120-02 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53863-120-02 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53863-120-02 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53863-120-02 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53863-120-02 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53863-120-02 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53863-120-02 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53863-120-02 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 53863-120-01 ExelSunscreen Creme SPF 37 50 mL in 1 BOTTLE CREAM 50 3 53863-120-02 ExelSunscreen Creme SPF 37 1 in 1 CARTON CREAM 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 OCTISALATE ACTIVE MOIETY 4X49Y0596W SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT 59TL3WG5CO SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 DMDM HYDANTOIN INACTIVE INGREDIENT BYR0546TOW SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 HAMAMELIS VIRGINIANA TOP INACTIVE INGREDIENT UDA30A2JJY SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 SHEA BUTTER INACTIVE INGREDIENT K49155WL9Y SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 WATER INACTIVE INGREDIENT 059QF0KO0R SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53863-120 SUNSCREEN CREME SPF 37 EXEL (OCTOCRYLENE,OCTINOXATE,OCTISALATE,OXYBENZONE,TITANIUM DIOXIDE) CREAM [EXELENCIA IMPORTERS CORP] 3 Legacy NDC, 2 package rows 20121106_bfcf87c0-27c4-4fba-9f4e-77e7132e073a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 53863-120-01 53863012001 50 mL in 1 BOTTLE 50 ml Historical 53863-120-02 53863012002 1 in 1 CARTON Historical