Home NDC 58443-0130-4 Ulta
Product NDC 58443-0130
Requested package NDC 58443-0130-4
11-digit product format 584430130
Labeler code 58443
Product ID 58443-0130_9c5ad950-d0a0-4d5a-e053-2a95a90a67d3
Type HUMAN OTC DRUG
Nonproprietary name Avobezone, Enzulizole, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2008-12-01
Marketing end 0000-00-00
Substance AVOBENZONE; ENSULIZOLE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 28 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ENSULIZOLE ACTIVE INGREDIENT 9YQ9DI1W42 ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ENSULIZOLE ACTIVE MOIETY 9YQ9DI1W42 ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 (C10-C30)ALKYL METHACRYLATE ESTER INACTIVE INGREDIENT XH2FQZ38D8 ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 DIETHYL (6-CHLORO-2-CARBAZOLYL)METHYLMALONATE INACTIVE INGREDIENT 74I9HB1BX3 ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERYL STEARATE CITRATE INACTIVE INGREDIENT WH8T92A065 ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 N-BUTYLPHTHALIMIDE INACTIVE INGREDIENT 5TH1DKT35E ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) INACTIVE INGREDIENT T9296U138P ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 TETRAETHYLAMMONIUM HYDROXIDE INACTIVE INGREDIENT RA8VU41B1F ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ULTA BROAD SPECTRUM SUNSCREEN SPF80 (AVOBEZONE, ENZULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0130-4 58443013004 148 mL in 1 TUBE (58443-0130-4) 148 ml 2008-12-01 0000-00-00 No No Current