Home NDC 65753-603 CorTex SunX 50 Thick
Product NDC 65753-603
11-digit product format 657530603
Labeler code 65753
Product ID 65753-603_4f1d54d8-37c3-ff62-e063-6394a90a458e
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler CoreTex Products Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-09
Substance HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength 10; 5; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 4 · 192 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 CorTex SunX 50 Thick
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 10 g/100mL OCTOCRYLENE 5 g/100mL OCTISALATE 5 g/100mL AVOBENZONE 3 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65753-603 CORTEX SUNX 50 THICK (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CORETEX PRODUCTS INC] 5 Current NDC, 19 package rows 20250209_f67a6c6c-c314-1c9d-e053-2a95a90a7f1a.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 99 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ALMOST powder MAKEUP BROAD SPECTRUM SPF 18 OCTINOXATE AND TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 402add6d-a81e-4c9e-aee1-4abeb480894f 2025-12-31 Warnings Exact identifier application number: M020 RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN ZINC OXIDE Formula 7venz L.L.C. e8e350e7-9225-4802-89a6-66e45ebc442d 2025-12-31 Warnings Exact identifier application number: M020 Kinfield Daily Dew Sea Kelp Moisturizer Sunscreen Broad Spectrum SPF 35 KINFIELD DAILY DEW SEA KELP MOISTURIZER SUNSCREEN LOTION BROAD SPECTRUM SPF 35 Kinfield, Inc. 0710db9f-fe91-4b98-a337-5fde33d98a9d 2025-12-30 Warnings Exact identifier application number: M020 Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35 KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35 Kinfield, Inc. 1030c5a4-3067-48e6-a21c-0d327ef434d0 2025-12-30 Warnings Exact identifier application number: M020 Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35 KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35 Kinfield, Inc. 612c5730-c3b4-486e-8ce9-8a861f676fa8 2025-12-30 Warnings Exact identifier application number: M020 Kinfield Liplock SPF 15 Lip Balm Broad Spectrum Sunscreen KINFIELD LIPLOCK SUNSCREEN Kinfield, Inc. 477aa1a2-c893-4750-84da-e5afe7ccd45b 2025-12-30 Warnings Exact identifier application number: M020 Kinfield Sunglow Luminizing Facial Sunscreen Broad Spectrum SPF 35 KINFIELD SUNGLOW LUMINIZING FACIAL SUNSCREEN BROAD SPECTRUM SPF 35 Kinfield, Inc. cbdfd0ae-514b-4b53-98ad-4270163bd0df 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Fair OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 472f4f34-99bc-2ff6-e063-6294a90a33c9 2025-12-30 Warnings Exact identifier application number: M020 EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45 ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE CLINIQUE LABORATORIES LLC 2397aca5-bf0a-619d-e063-6394a90a7ab9 2025-12-30 Warnings Exact identifier application number: M020 Resource Essentials Sun Protection Mineral SPF 30 14% ZINC OXIDE Skinresource.md, L.L.C. 45b486cf-28ee-6392-e063-6394a90affb0 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Light Medium OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47313277-8884-70b5-e063-6394a90a5fca 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Medium OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47320858-0aea-6ee9-e063-6294a90a9fa9 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Light Warm OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47325530-b097-db9a-e063-6294a90a335d 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Tan OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47328eb4-8ad7-28b5-e063-6294a90a20b1 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Tan Deep OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4732bbec-d9f9-1639-e063-6394a90aff82 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Deep OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4732ecd0-5261-7f11-e063-6394a90a26f3 2025-12-30 Warnings Exact identifier application number: M020 ScalpProtectionSpray SCALP PROTECTION SPRAY Naturich Labs c227ff3a-bbbb-5cc5-e053-2a95a90a8e32 2025-12-30 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 0918fdd3-cffb-78e9-e063-6394a90ad5c7 2025-12-30 Warnings Exact identifier application number: M020 SLMD AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Skin PS Brands 1aa36c01-21b5-f06e-e063-6294a90a608f 2025-12-30 Warnings Exact identifier application number: M020 Ageless Glow Serum BB Cream Sunscreen SPF 40 - Fair HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 473738b4-7c36-8edf-e063-6394a90ad24b 2025-12-30 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65753-603-01 65753060301 30 mL in 1 BOTTLE (65753-603-01) 30 ml 2023-03-09 No No Current 65753-603-02 65753060302 60 mL in 1 BOTTLE (65753-603-02) 60 ml 2023-03-09 No No Current 65753-603-03 65753060303 120 mL in 1 BOTTLE (65753-603-03) 120 ml 2023-03-09 No No Current 65753-603-04 65753060304 177 mL in 1 BOTTLE (65753-603-04) 177 ml 2023-03-09 No No Current 65753-603-05 65753060305 237 mL in 1 BOTTLE (65753-603-05) 237 ml 2023-03-09 No No Current 65753-603-07 65753060307 473 mL in 1 BOTTLE (65753-603-07) 473 ml 2023-03-09 No No Current 65753-603-08 65753060308 762 mL in 1 BOTTLE, DISPENSING (65753-603-08) 762 ml 2023-03-09 No No Current 65753-603-09 65753060309 960 mL in 1 BOTTLE (65753-603-09) 960 ml 2023-03-09 No No Current 65753-603-10 65753060310 3800 mL in 1 BOTTLE (65753-603-10) 3800 ml 2023-03-09 No No Current 65753-603-22 65753060322 25 POUCH in 1 CONTAINER (65753-603-22) / 7 mL in 1 POUCH (65753-603-39) 25 pouch 2023-03-09 No No Current 65753-603-23 65753060323 25 POUCH in 1 CONTAINER (65753-603-23) / 7 mL in 1 POUCH (65753-603-39) 25 pouch 2023-03-09 No No Current 65753-603-24 65753060324 50 POUCH in 1 CONTAINER (65753-603-24) / 7 mL in 1 POUCH (65753-603-39) 50 pouch 2023-03-09 No No Current 65753-603-25 65753060325 100 POUCH in 1 CONTAINER (65753-603-25) / 7 mL in 1 POUCH (65753-603-39) 100 pouch 2023-03-09 No No Current 65753-603-26 65753060326 150 POUCH in 1 CARTON (65753-603-26) / 7 mL in 1 POUCH (65753-603-39) 150 pouch 2023-03-09 No No Current 65753-603-32 65753060332 44 mL in 1 BOTTLE (65753-603-32) 44 ml 2023-03-09 No No Current 65753-603-33 65753060333 60 mL in 1 BOTTLE (65753-603-33) 60 ml 2023-03-09 No No Current 65753-603-34 65753060334 120 mL in 1 BOTTLE (65753-603-34) 120 ml 2023-03-09 No No Current 65753-603-35 65753060335 762 mL in 1 BOTTLE (65753-603-35) 762 ml 2023-03-09 No No Current 65753-603-39 65753060339 7 mL in 1 POUCH (65753-603-39) 7 ml 2023-03-09 No No Current