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 3 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sunski Hot Block Mineral Sunscreen Stick SPF 50 ZINC OXIDE Stewart Charley Ventures LLC dba Sunski 04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a8 2026-09-01 Warnings Exact identifier application number: M020 Sun Wave Anti Aging Insta Dry SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Life Brands, LLC 7e48a3d2-e453-4733-b42b-8bea804cda59 2026-09-01 Warnings Exact identifier application number: M020 Sun Wave Anti Aging Lite SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Life Brands, LLC 7204c24f-aab6-45eb-9bd4-879f715ba075 2026-09-01 Warnings Exact identifier application number: M020 Sun Wave Anti Aging Lite SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Life Brands, LLC 7c1e780a-1831-4f49-a92e-e36017d241a2 2026-09-01 Warnings Exact identifier application number: M020 Sun Wave Cross Sport Insta Dry SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Life Brands, LLC d45614c8-b09c-417b-b691-082ea2149880 2026-09-01 Warnings Exact identifier application number: M020 Sun Wave Cross Sport Insta Dry SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Life Brands, LLC 999b0b17-be73-4d42-b182-ce038f493301 2026-09-01 Warnings Exact identifier application number: M020 Sun Wave Cross Sport Insta Dry SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Life Brands, LLC adffff46-4cfb-4c0a-b1a6-75220ee193a5 2026-09-01 Warnings Exact identifier application number: M020 Sun Wave Cross Sport Insta Dry SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Life Brands, LLC 13b2b45b-70e1-46ff-8555-48e1fe98c651 2026-09-01 Warnings Exact identifier application number: M020 Sun Wave Kids Insta Dry SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Life Brands, LLC 5c2a5ca3-e9eb-48ba-8698-592d2c7aa241 2026-09-01 Warnings Exact identifier application number: M020 Sunceutical SPF 50 Mineral Face Cream ZINC OXIDE Baxter Laboratories Pty. Ltd. 2c408728-a1de-d51e-e063-6294a90ade0b 2026-08-31 Warnings Exact identifier application number: M020 SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE Craver Corporation 38d8c1c9-86b5-1edd-e063-6394a90aeb47 2026-08-30 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID DAILY SUNGEL AVOBENZONE, HOMOSALATE, OCTISALATE ISNTREE Inc. 5a3a17ff-a7fd-f707-e063-6394a90a3182 2026-08-29 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID NATURAL SUNCREAM ZINC OXIDE ISNTREE Inc. 5a3a59b2-18b6-521b-e063-6294a90a2958 2026-08-29 Warnings Exact identifier application number: M020 Cetaphil Daily Facial Moisturizer with suncreen SPF 35 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Galderma Laboratories, L.P. f5eb347f-0d46-4de6-8f3f-9010327678ed 2026-08-28 Warnings Exact identifier application number: M020 Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen ZINC OXIDE Utu Co 59938ace-c97c-d758-e063-6394a90a77e4 2026-08-28 Warnings Exact identifier application number: M020 Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen Unscented ZINC OXIDE Utu Co 5982e790-7cdb-c96c-e063-6394a90a02d4 2026-08-28 Warnings Exact identifier application number: M020 Utu Hydrating Sun Balm Broad Spectrum SPF 50 ZINC OXIDE Utu Co 59d1d0ac-2444-d6f9-e063-6294a90ae80c 2026-08-28 Warnings Exact identifier application number: M020 Hello Bello Mineral Sunscreen SPF 50 ZINC OXIDE Topiderm, Inc. 54f12764-5c37-4a05-bf96-209fedb93fd1 2026-08-28 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID DAILY SUNGEL AVOBENZONE, HOMOSALATE, OCTISALATE ISNTREE Inc. 5a02c540-5b3b-9379-e063-6294a90a00f6 2026-08-27 Warnings Exact identifier application number: M020 MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50 SUNSCREEN SPF50 Guangzhou Meixi Biotechnology Co., Ltd. 5a0b4bd2-f6ad-35dc-e063-6294a90a8a66 2026-08-27 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