Home NDC 13630-0091-4 MKRS
Product NDC 13630-0091
Requested package NDC 13630-0091-4
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 · 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 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 41 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Light Medium ZINC OXIDE ZO Skin Health, Inc. 4fabe9d0-27fe-230f-e063-6294a90a9ac0 2026-04-17 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Medium-Tan ZINC OXIDE ZO Skin Health, Inc. 4fac82b7-d685-2a0d-e063-6394a90aa795 2026-04-17 Warnings Exact identifier application number: M020 SALT WATER VANILLA SUNSCREEN BODY BROAD SPECTRUM SPF 50 SUNSCREEN Saltair Body LLC 4fae649d-f60e-0275-e063-6294a90a1ea5 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEP YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e246e64-2eab-1219-e063-6294a90a79a8 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316cd8a3-3d62-83ac-e063-6394a90a4afa 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e2424f4-0011-42b0-e063-6394a90a780d 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHT YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316cfaea-b71f-2956-e063-6294a90a4f20 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316d1515-6092-a7d6-e063-6394a90ab8b2 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEP YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e246e70-6ec3-5711-e063-6394a90a3879 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e241343-db63-3f1c-e063-6394a90ab538 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316df5fe-0574-d59f-e063-6294a90af8b9 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316c5d69-46f4-7677-e063-6294a90a610f 2026-04-17 Warnings Exact identifier application number: M020 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 PML NYC, LLC 316d905f-232c-d8a2-e063-6394a90adbc9 2026-04-17 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 230 N PML NYC, LLC 316ea01b-4bff-55be-e063-6394a90add94 2026-04-17 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 410 N PML NYC, LLC 316e97bc-4b96-ba6e-e063-6294a90a7648 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c781d7-9d48-892f-e053-2a95a90aca86 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c757b4-6c92-18f0-e053-2a95a90a246d 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c76a82-dc87-35e7-e053-2995a90ae310 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7ac71-3f38-52b2-e053-2a95a90ab54e 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7b929-7492-f072-e053-2995a90a1ca3 2026-04-17 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 2022-06-30 No No Current