Home NDC 76450-051-01 DERMATOLOGICAL SUN PROTECTION
Product NDC 76450-051
Requested package NDC 76450-051-01
11-digit product format 764500051
Labeler code 76450
Product ID 76450-051_b9f6734e-fdea-7a96-e053-2995a90ab481
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, OXYBENZONE, ENSULIZOLE, OCTOCRYLENE, OCTINOXATE, TITANIUM DIOXIDE
Dosage form LOTION
Route TOPICAL
Labeler Mesoestetic, S.L.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-02-01
Marketing end 2021-04-30
Substance AVOBENZONE; OXYBENZONE; ENSULIZOLE; OCTOCRYLENE; OCTINOXATE; TITANIUM DIOXIDE
Active strength 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 ENSULIZOLE ACTIVE INGREDIENT 9YQ9DI1W42 DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 ENSULIZOLE ACTIVE MOIETY 9YQ9DI1W42 DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) INACTIVE INGREDIENT 59TL3WG5CO DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 DODICIN INACTIVE INGREDIENT 72T37AL5JV DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 GLYCINE INACTIVE INGREDIENT TE7660XO1C DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 ISOSTEARYL NEOPENTANOATE INACTIVE INGREDIENT 411THY156Q DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 LAURYL AMINOPROPYLGLYCINE INACTIVE INGREDIENT 68Q1A0Y4GX DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 METHYLCHLOROISOTHIAZOLINONE INACTIVE INGREDIENT DEL7T5QRPN DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 POLYGLYCERYL-3 DIISOSTEARATE INACTIVE INGREDIENT 46P231IQV8 DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) INACTIVE INGREDIENT 59Z907ZB69 DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 SERINE INACTIVE INGREDIENT 452VLY9402 DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 SODIUM LACTATE INACTIVE INGREDIENT TU7HW0W0QT DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 SODIUM OLEATE INACTIVE INGREDIENT 399SL044HN DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 SORBITAN ISOSTEARATE INACTIVE INGREDIENT 01S2G2C1E4 DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 UREA INACTIVE INGREDIENT 8W8T17847W DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DERMATOLOGICAL SUN PROTECTION (OCTINOXATE) LOTION [MESOESTETIC, S.L.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76450-051-01 76450005101 50 mL in 1 TUBE (76450-051-01) 50 ml 2012-02-01 2021-04-30 No No Current