Home NDC 51191-3015-1 SPF 50 UVA/UVB
Product NDC 51191-3015
Requested package NDC 51191-3015-1
11-digit product format 511913015
Labeler code 51191
Product ID 51191-3015_b0368e3c-741f-4b9d-bd29-4fdc17d6a51a
Type HUMAN OTC DRUG
Nonproprietary name ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE
Dosage form CREAM
Route TOPICAL
Labeler MULTALER ET CIE S.A.S.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2013-04-15
Marketing end 0000-00-00
Substance OCTOCRYLENE; OXYBENZONE; AVOBENZONE; ENSULIZOLE
Active strength 8 g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2022-12-31
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 · 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 ENSULIZOLE ACTIVE INGREDIENT 9YQ9DI1W42 SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 AVOBENZONE ACTIVE MOIETY G63QQF2NOX SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 ENSULIZOLE ACTIVE MOIETY 9YQ9DI1W42 SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 .ALPHA.-BISABOLOL, (+/-)- INACTIVE INGREDIENT 36HQN158VC SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 APRICOT KERNEL OIL INACTIVE INGREDIENT 54JB35T06A SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 ASPALATHUS LINEARIS LEAF INACTIVE INGREDIENT H7UGK1GJCU SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 CHLORPHENESIN INACTIVE INGREDIENT I670DAL4SZ SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 GLYCYRRHIZINATE DIPOTASSIUM INACTIVE INGREDIENT CA2Y0FE3FX SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 PEG-8/SMDI COPOLYMER INACTIVE INGREDIENT CCX72L6NY6 SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) INACTIVE INGREDIENT 1DXE3F3OZX SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 TEA LEAF INACTIVE INGREDIENT GH42T47V24 SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SPF 50 UVA/UVB (ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [MULTALER ET CIE S.A.S.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51191-3015-1 51191301501 50 g in 1 TUBE (51191-3015-1) 50 g 2013-04-15 0000-00-00 No No Current