Home NDC 58443-0127 Ulta
Product NDC 58443-0127
11-digit product format 584430127
Labeler code 58443
Product ID 58443-0127_9c5a9555-ba23-7ea5-e053-2a95a90a10ec
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octisalate, and Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2008-01-01
Marketing end 0000-00-00
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength 19 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58443-0127-4 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58443-0127-4 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58443-0127-4 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58443-0127-4 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58443-0127-4 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58443-0127-4 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58443-0127-4 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58443-0127-4 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58443-0127-4 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58443-0127-4 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58443-0127-4 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58443-0127-4 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 SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 2,6-DI-TERT-BUTYL-4-((METHYLTHIO)METHYL)PHENOL INACTIVE INGREDIENT 650986R470 ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CALENDULA OFFICINALIS FLOWER INACTIVE INGREDIENT P0M7O4Y7YD ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CARAMEL INACTIVE INGREDIENT T9D99G2B1R ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CETEARETH-22 INACTIVE INGREDIENT 28VZG1E234 ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 DIHYDROXYACETONE INACTIVE INGREDIENT O10DDW6JOO ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERYL DILAURATE INACTIVE INGREDIENT MFL3ZIE8SK ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 L-ERYTHRULOSE INACTIVE INGREDIENT WKK1W5B83O ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 MATRICARIA CHAMOMILLA FLOWERING TOP OIL INACTIVE INGREDIENT SA8AR2W4ER ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 N-BUTYLPHTHALIMIDE INACTIVE INGREDIENT 5TH1DKT35E ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ULTA SPF 15 LIGHT MEDIUM BROAD SPECTRUM (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) 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 58443-0127-4 58443012704 177 mL in 1 TUBE (58443-0127-4) 177 ml 2008-01-01 0000-00-00 No No Current