Home NDC 44099-011 skin MD
Product NDC 44099-011
11-digit product format 440990011
Labeler code 44099
Product ID 44099-011_4384c3d1-e160-67fa-e063-6394a90a0a42
Type HUMAN OTC DRUG
Nonproprietary name octinoxate, octisalate, homosalate
Dosage form LOTION
Route TOPICAL
Labeler 21st Century Formulations
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-08-19
Substance OCTINOXATE; OCTISALATE; HOMOSALATE
Active strength 7; 5; 3 mg/100mL; mg/100mL; mg/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 44099-011-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 44099-011-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 44099-011-03 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 44099-011-04 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 44099-011-03 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 44099-011-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 44099-011-05 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 44099-011-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 44099-011-04 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 44099-011-03 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 44099-011-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 44099-011-05 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 44099-011-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base skin MD
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 7 mg/100mL OCTISALATE 5 mg/100mL HOMOSALATE 3 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 4X49Y0596W Internal UNII lookup V06SV4M95S Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44099-011-01 skin MD 117 mL in 1 BOTTLE LOTION 117 7 44099-011-02 skin MD 236 mL in 1 BOTTLE LOTION 236 7 44099-011-03 skin MD 3785 mL in 1 BOTTLE LOTION 3785 7 44099-011-04 skin MD 100 mL in 1 TUBE LOTION 100 7 44099-011-05 skin MD 200 mL in 1 TUBE LOTION 200 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44099-011 SKIN MD (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [21ST CENTURY FORMULATIONS] 6 Current NDC, Legacy NDC, 5 package rows 20250406_e809e1d3-0a6d-730d-e053-2a95a90aedb9.zip
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 38 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN ZINC OXIDE Zouck LLC 507560fe-c7ad-329a-e063-6394a90a039a 2026-04-27 Warnings Exact identifier application number: M020 SoloVegan HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE YES SALES INC. 435748e6-c39a-efee-e063-6294a90ad0e5 2026-04-27 Warnings Exact identifier application number: M020 SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREEN ZINC OXIDE Zouck LLC 50764f40-7881-81a3-e063-6294a90ad1cf 2026-04-27 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Antioxidant Protocol AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE Obagi Cosmeceuticals LLC 495bc176-b292-448f-a5a6-00de2e475e54 2026-04-27 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f45bd7bd-a802-33e4-e053-2a95a90a61a7 2026-04-23 Warnings Exact identifier application number: M020 TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER PML NYC, LLC 1c2e9b0d-ba0e-1767-e063-6394a90a756c 2026-04-23 Warnings Exact identifier application number: M020 Skincare LdeL Retinol Day Broad Spectrum SPF 20 AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATE Beauty Solutions, Ltd. 76e2ed34-c643-402b-9c9d-04eac789d3c2 2026-04-22 Warnings Exact identifier application number: M020 Johnsons Baby Mineral Sunscreen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 4fe04c4b-2751-0561-e063-6394a90af768 2026-04-22 Warnings Exact identifier application number: M020 Johnsons Baby Mineral Sunscreen Stick SPF 50 ZINC OXIDE Kenvue Brands LLC 4fe1d3c6-7748-d966-e063-6394a90a97ff 2026-04-22 Warnings Exact identifier application number: M020 OVERLAPS ECTOIN MOIST SUN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Overlaps Corp. 4c3ed60b-e515-8ff0-e063-6294a90a86df 2026-04-22 Warnings Exact identifier application number: M020 Lazy Face SPF 30 Facescreen TITANIUM DIOXIDE, ZINC OXIDE Sunny Day Creations 500ee303-7302-68d5-e063-6394a90ac6d4 2026-04-22 Warnings Exact identifier application number: M020 Lazy Face SPF 30 Facestick ZINC OXIDE Sunny Day Creations 50101b55-793e-dbe4-e063-6394a90a6199 2026-04-22 Warnings Exact identifier application number: M020 Broad Spectrum Sunscreen SPF 30 OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3% S&C Hampton Sun LLC e6103de6-1d80-46fd-b9d4-893f60941def 2026-04-22 Warnings Exact identifier application number: M020 PhotoAge Guard AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE MACROMOTION, INC. 50164bd8-469d-9ec1-e063-6294a90a543d 2026-04-22 Warnings Exact identifier application number: M020 THANK YOU FARMER Sun Project Silky Calming Sun Stick AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE THANK YOU FARMER CO., LTD 49947114-5137-dc45-e063-6394a90ad9d0 2026-04-22 Warnings Exact identifier application number: M020 Sky and Sol Intense Healing Lip Jelly NON-NANO ZINC OXIDE Delta Ecommerce LLC 2ddaa215-7433-c8fa-e063-6394a90a4316 2026-04-22 Warnings Exact identifier application number: M020 Broad Spectrum SPF45 ZINC OXIDE, OCTINOXATE Drmtlgy, LLC 0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8 2026-04-21 Warnings Exact identifier application number: M020 BLDG Active Skin Repair Face and Body Performance Sunscreen ZINC OXIDE Innovacyn, Inc. 70cb98cf-739b-4d46-b45a-535ff0a4531c 2026-04-21 Warnings Exact identifier application number: M020 Freaks of Nature Mineral Sunscreen ZINC OXIDE MINERAL SUNSCREEN Empack Spraytech Inc. 4ffdb1c6-b2c6-628f-e063-6394a90a2769 2026-04-21 Warnings Exact identifier application number: M020 THANK YOU FARMER Sun Project Water Sun Cream AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE THANK YOU FARMER CO., LTD 5004126b-0a9c-21fb-e063-6294a90a5237 2026-04-21 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 44099-011-01 44099001101 117 mL in 1 BOTTLE (44099-011-01) 117 ml 2008-08-19 0000-00-00 No No Current 44099-011-02 44099001102 236 mL in 1 BOTTLE (44099-011-02) 236 ml 2008-08-19 0000-00-00 No No Current 44099-011-03 44099001103 3785 mL in 1 BOTTLE (44099-011-03) 3785 ml 2008-08-19 0000-00-00 No No Current 44099-011-04 44099001104 100 mL in 1 TUBE (44099-011-04) 100 ml 2018-07-16 0000-00-00 No No Current 44099-011-05 44099001105 200 mL in 1 TUBE (44099-011-05) 200 ml 2018-07-16 0000-00-00 No No Current