Home NDC 58443-0105 SolMate
Product NDC 58443-0105
11-digit product format 584430105
Labeler code 58443
Product ID 58443-0105_9c5801de-4d18-f8a3-e053-2a95a90afce0
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 2013-08-28
Marketing end 0000-00-00
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength 20 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 · 30 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 58443-0105-4 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 58443-0105-4 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 58443-0105-4 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 58443-0105-4 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 58443-0105-4 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 58443-0105-4 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 58443-0105-4 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 58443-0105-4 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 58443-0105-4 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 58443-0105-4 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 58443-0105-4 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 58443-0105-4 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58443-0105-4 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58443-0105-4 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58443-0105-4 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58443-0105-4 SolMateBROAD SPECTRUM SPF 15 177 mL in 1 BOTTLE LOTION 177 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 (C10-C30)ALKYL METHACRYLATE ESTER INACTIVE INGREDIENT XH2FQZ38D8 SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CARBOMER 940 INACTIVE INGREDIENT 4Q93RCW27E SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 N-BUTYLPHTHALIMIDE INACTIVE INGREDIENT 5TH1DKT35E SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0105 SOLMATE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 3 Legacy NDC, 1 package rows 20200118_0eb6d5ee-c7ee-4cad-b6de-f04bcc9464ca.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0105-4 58443010504 177 mL in 1 BOTTLE (58443-0105-4) 177 ml 2013-08-28 0000-00-00 No No Current