Home NDC 13630-0091 MKRS
Product NDC 13630-0091
11-digit product format 136300091
Labeler code 13630
Product ID 13630-0091_e1f7b435-c0f8-2220-e053-2a95a90a9d47
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Prime Packaging, Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-01
Marketing end 2022-06-30
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
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 13630-0091-4 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 13630-0091-4 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 13630-0091-4 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 13630-0091-4 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 13630-0091-4 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 13630-0091-4 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 13630-0091-4 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 13630-0091-4 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 13630-0091-4 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 13630-0091-4 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 13630-0091-4 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 13630-0091-4 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 MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 BUTYL MALEURATE INACTIVE INGREDIENT 6FUA0H660I MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 ISOBORNYL ACRYLATE INACTIVE INGREDIENT IX0PRH184P MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A MKRS BROAD SPECTRUM SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.] 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 160 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Huey Daily Mineral TITANIUM DIOXIDE, ZINC OXIDE Huey 15bdf9c6-3bfa-4eef-e063-6294a90a195f 2025-11-14 Warnings Exact identifier application number: M020 Pipette Diaper Rash ZINC OXIDE Pipette LLC 2a93998c-1855-9207-e063-6294a90ab0e9 2025-11-14 Warnings Exact identifier application number: M020 Ware Sonny Universal TITANIUM DIOXIDE, ZINC OXIDE Ware Cosmetics fe2b9d16-9215-e21e-e053-6394a90a5156 2025-11-14 Warnings Exact identifier application number: M020 YAY NOVELTY ALL-IN-ONE TITANIUM DIOXIDE, ZINC OXIDE YAY Novelty fb833158-d0d8-de7f-e053-6294a90adc5a 2025-11-14 Warnings Exact identifier application number: M020 Thu Brule Free Spirit Correct and Protect TITANIUM DIOXIDE, ZINC OXIDE Laughing Buddha LLC 258a4f97-d811-0521-e063-6394a90aaf3b 2025-11-14 Warnings Exact identifier application number: M020 Alpha-H Total Eclipse TITANIUM DIOXIDE, ZINC OXIDE Alpha-H fc8a4efe-7d5e-5f44-e053-6394a90a80aa 2025-11-14 Warnings Exact identifier application number: M020 Svens Everyday Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Svens, Inc 912170ae-124c-5eb9-e053-2995a90a0ba3 2025-11-14 Warnings Exact identifier application number: M020 Wander Beauty Pack Up and Glow Priming TITANIUM DIOXIDE, ZINC OXIDE Wander Beauty 3d844efc-091c-9a9b-e063-6294a90aee7c 2025-11-14 Warnings Exact identifier application number: M020 Baby Bare Republic Mineral Sunscreen ZINC OXIDE COOLA, LLC b292d1a9-7ff8-0faf-e053-2995a90ae342 2025-11-14 Warnings Exact identifier application number: M020 Aspen Islanders Sheer Mineral Sport ZINC OXIDE Aspen Islanders LLC 0fcb2adf-71c9-3369-e063-6294a90aa806 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE MALON DAZE By the Beach Suncare LLC 4391728b-dfe7-3ffb-e063-6394a90a240e 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE CITRUS CRUSH By the Beach Suncare LLC 43918d25-e947-5e17-e063-6394a90ada7c 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE CANDY CLOUDS By the Beach Suncare LLC 4391728b-dfe8-3ffb-e063-6394a90a240e 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Balance and Clear ZINC OXIDE Sunsolve MD Inc 26f3595d-adef-a8a5-e063-6394a90adfd4 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Detox and Shield ZINC OXIDE Sunsolve MD Inc 26f3886b-a3a5-c9b7-e063-6394a90af6c3 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Amber 002 ZINC OXIDE Sunsolve MD Inc 26e00001-9c68-0734-e063-6394a90a1787 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Agate 003 ZINC OXIDE Sunsolve MD Inc 26e00001-9c6f-0734-e063-6394a90a1787 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Bronzite 004 ZINC OXIDE Sunsolve MD Inc 26e13356-9ab5-246a-e063-6394a90a2a70 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Onyx 006 ZINC OXIDE Sunsolve MD Inc 26e16b5e-dd2e-6fb8-e063-6394a90a6a7f 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Calm and Revitalize ZINC OXIDE Sunsolve MD Inc 26f3f534-a305-3530-e063-6394a90a75e1 2025-11-14 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13630-0091-4 13630009104 177 mL in 1 CAN (13630-0091-4) 177 ml 2015-08-01 0000-00-00 No No Current