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 42 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EltaMD UV Restore Tinted TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN CP Skin Health Group, Inc. 6a48ad0d-20e4-44b1-90d6-30bfbc68a152 2026-04-17 Warnings Exact identifier application number: M020 Pacto Refreshing Sunscreen Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Mynd LLC 56ad7c97-3dae-4bac-a677-f5052dfdfea4 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f95cd0a-f996-648b-e063-6294a90adc28 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f968058-e851-86d0-e063-6294a90aa786 2026-04-16 Warnings Exact identifier application number: M020 Red Cherry SPF 15 Broad Spectrum Lip Balm RED CHERRY SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc 4f96d057-39b8-e4d5-e063-6394a90acb5c 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-Light ZINC OXIDE ZO Skin Health, Inc. 4f9988a0-ae4a-9940-e063-6294a90ad91d 2026-04-16 Warnings Exact identifier application number: M020 MELAO Hydrating Mineral Sunscreen TITANIUM DIOXIDE,ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4f778eb0-55f7-38d0-e063-6394a90a69a0 2026-04-15 Warnings Exact identifier application number: M020 Tanning Club Everyday Sunscreen SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE TANNING CLUB, LLC 75820400-a5e0-4cf5-8b4f-a52500ce62c3 2026-04-15 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f8353b3-4ac1-9703-e063-6294a90abdad 2026-04-15 Warnings Exact identifier application number: M020 Mineral Sunscreen Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f83dd76-a8d8-916e-e063-6294a90ab6ed 2026-04-15 Warnings Exact identifier application number: M020 Mineral Sunscreen Stick - Tinted TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f84619f-3415-7443-e063-6394a90a162a 2026-04-15 Warnings Exact identifier application number: M020 Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory TITANIUM DIOXIDE AND ZINC OXIDE PML NYC, LLC 1be639a8-179a-7015-e063-6394a90ab64b 2026-04-15 Warnings Exact identifier application number: M020 PHELITYL DAY SPF 15 PHELITYL DAY SPF 15 PML NYC, LLC ea9d33d9-6f9f-0a66-e053-2a95a90abd42 2026-04-15 Warnings Exact identifier application number: M020 FIRMARINE MOISTURIZER SPF 30 FIRMARINE MOISTURIZER SPF 30 PML NYC, LLC ea9db179-1b69-01e0-e053-2a95a90a1628 2026-04-15 Warnings Exact identifier application number: M020 EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15 EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15 PML NYC, LLC eaa562b1-3fc6-1a85-e053-2995a90ad1ec 2026-04-15 Warnings Exact identifier application number: M020 DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30 DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30 PML NYC, LLC ea90bb4d-6f4a-45c9-e053-2a95a90a53a7 2026-04-15 Warnings Exact identifier application number: M020 RICH GIRL HAND SPF 25 RICH GIRL HAND PML NYC, LLC ea8f4421-109f-41a5-e053-2a95a90a3832 2026-04-15 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTER YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e24a63e-d76f-6581-e063-6394a90a6181 2026-04-15 Warnings Exact identifier application number: M020 JAFRA SUN Facial Sunscreen COLOR MATCH BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTES AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. cf33c5a1-b7c5-4c5a-9981-e4e24208cd11 2026-04-15 Warnings Exact identifier application number: M020 JAFRA SUN Facial Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTES AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. 56c124d7-0b8c-4bb9-8261-c7395353fbe0 2026-04-15 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