Home NDC 58443-0126-4 Ulta
Product NDC 58443-0126
Requested package NDC 58443-0126-4
11-digit product format 584430126
Labeler code 58443
Product ID 58443-0126_9c5ae2e2-d03b-84d9-e053-2995a90ac7b5
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, and Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2007-03-12
Marketing end 0000-00-00
Substance OCTISALATE; OXYBENZONE; OCTINOXATE
Active strength 28 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 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 (C10-C30)ALKYL METHACRYLATE ESTER INACTIVE INGREDIENT XH2FQZ38D8 ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 COLLAGEN, SOLUBLE, FISH SKIN INACTIVE INGREDIENT 8JC99XGU4W ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERYL STEARATE CITRATE INACTIVE INGREDIENT WH8T92A065 ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 N-BUTYLPHTHALIMIDE INACTIVE INGREDIENT 5TH1DKT35E ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 TETRAETHYLAMMONIUM HYDROXIDE INACTIVE INGREDIENT RA8VU41B1F ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK ULTA SUNSCREEN SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ULTA SUNSCREEN SPF 15 (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 58443-0126-4 58443012604 177 mL in 1 TUBE (58443-0126-4) 177 ml 2007-03-12 0000-00-00 No No Current