Home NDC 58443-0111-4 ULTA
Product NDC 58443-0111
Requested package NDC 58443-0111-4
11-digit product format 584430111
Labeler code 58443
Product ID 58443-0111_9c5ad950-d0bf-4d5a-e053-2a95a90a67d3
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octinoxate, Octisalate, and Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-04-23
Marketing end 0000-00-00
Substance HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength 57 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 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 (C10-C30)ALKYL METHACRYLATE ESTER INACTIVE INGREDIENT XH2FQZ38D8 ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 MARINE COLLAGEN, SOLUBLE INACTIVE INGREDIENT 8JC99XGU4W ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 N-BUTYLPHTHALIMIDE INACTIVE INGREDIENT 5TH1DKT35E ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ULTA OIL FREE SUNSCREEN SPF30 (HOMOSALATE, OCTINOXATE, OCTISALATE, 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 58443-0111-4 58443011104 177 mL in 1 BOTTLE (58443-0111-4) 177 ml 2013-04-23 0000-00-00 No No Current