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 130 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prevention 2 Acne Safe Facial Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373c0ab0-8828-542b-e063-6394a90a8633 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373ddad0-ed33-a233-e063-6294a90a19cd 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37263083-b24f-5a71-e063-6294a90aee7d 2025-12-11 Exact identifier application number: M020 Prevention Acne Safe Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373d4fad-141c-0904-e063-6394a90a9759 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37265b3d-92ef-ef4a-e063-6294a90a8d95 2025-12-11 Exact identifier application number: M020 Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373d902f-f7b6-298b-e063-6394a90a9307 2025-12-11 Exact identifier application number: M020 Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726c177-2912-a6cc-e063-6394a90a0043 2025-12-11 Exact identifier application number: M020 Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726f463-7e55-c2a2-e063-6394a90a3c51 2025-12-11 Exact identifier application number: M020 Mattify Total Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37617bd5-c275-aeee-e063-6394a90a214d 2025-12-11 Exact identifier application number: M020 Not YO 80s Zinc Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37644dfd-e96d-a783-e063-6294a90a9796 2025-12-11 Exact identifier application number: M020 Not YO 80s Zinc Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 3762f132-4ab0-74ad-e063-6394a90a436c 2025-12-11 Exact identifier application number: M020 GLOW UP Ageless Daily Protection Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37637e45-c6ed-12ca-e063-6294a90aeb02 2025-12-11 Exact identifier application number: M020 Face and Body Sunscreen ZINC OXIDE SCIENCE CEUTICALS, LLC 369b42f3-5203-87c4-e063-6394a90a6284 2025-12-11 Exact identifier application number: M020 Nourish Non-Tinted Mineral Sunscreen ZINC OXIDE Fern Burg 34a32097-de93-9b1d-e063-6394a90a41df 2025-12-11 Exact identifier application number: M020 Mattify Total Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37641f8b-0133-8bfc-e063-6294a90aac5c 2025-12-11 Exact identifier application number: M020 GLOW UP Ageless Daily Protection Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 3764856a-98c5-334e-e063-6394a90a629d 2025-12-11 Exact identifier application number: M020 Essential Mineral Sun Protection TITANIUM DIOXIDE, ZINC OXIDE Fern Burg 34a360b2-6798-c7e8-e063-6294a90a5cbb 2025-12-11 Exact identifier application number: M020 Nourish Non-Tinted Mineral Sunscreen ZINC OXIDE Fern Burg 34a3e268-e376-11a0-e063-6294a90a46af 2025-12-11 Exact identifier application number: M020 Tinted Mineral Matte CE Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b72d14-b69b-e9dd-e063-6394a90a748e 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SCIENCE CEUTICALS, LLC 369b20e2-2cad-e047-e063-6294a90a1bba 2025-12-11 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