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 23 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Violette Preen Screen Broad Spectrum SPF 50 AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Grace and Fire USA Inc. 26a0fc0d-a903-2ac1-e063-6394a90a13db 2026-06-01 Warnings Exact identifier application number: M020 Timesavvy Hybrid XL Cushion Sun Serum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE ProBetter USA, Inc. 82a22071-f1bd-4fab-b929-8a00ef18f0d9 2026-05-31 Warnings Exact identifier application number: M020 Marine Screen Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE OSEA International, LLC 9aa20377-0ab9-4205-b9aa-24640a4641e7 2026-05-29 Warnings Exact identifier application number: M020 Ciele Blush and Protect Sugar ZINC OXIDE Ciele LLC 52f3a9f6-a226-6723-e063-6394a90a8706 2026-05-29 Warnings Exact identifier application number: M020 KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN TITANIUM DIOXIDE AND ZINC OXIDE LOreal USA Products Inc 294e6049-12b5-4b45-ae00-8ee1d9d2a1a4 2026-05-29 Warnings Exact identifier application number: M020 Daily Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 52f818f4-8485-b228-e063-6294a90a9fe3 2026-05-29 Warnings Exact identifier application number: M020 Dr.G BRIGHT TONING UP TINTED SUNSCREEN ZINC OXIDE, OCTISALATE, HOMOSALATE GOWOONSESANG COSMETICS CO., LTD. 30d34459-b7fb-b0c6-e063-6294a90a08ac 2026-05-28 Warnings Exact identifier application number: M020 Dr.G GREEN MILD UP DEFENSE MINERAL SUNSCREEN ZINC OXIDE GOWOONSESANG COSMETICS CO., LTD. 30d49f24-3e13-385f-e063-6294a90ab5c8 2026-05-28 Warnings Exact identifier application number: M020 Dr.G R.E.D BLEMISH SOOTHING UP MOISTURE SUNSCREEN HOMOSALATE, OCTISALATE, AVOBENZONE GOWOONSESANG COSMETICS CO., LTD. 30d53b8a-7e35-0b2b-e063-6294a90aa8df 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect Berri ZINC OXIDE Ciele LLC 52e16cbc-b452-db18-e063-6394a90a4081 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect June ZINC OXIDE Ciele LLC 52e1c504-f0ee-2853-e063-6394a90a3139 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect January ZINC OXIDE Ciele LLC 52e186df-06aa-6528-e063-6294a90a3888 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect Berri ZINC OXIDE Ciele LLC 52e1398d-b170-ea89-e063-6294a90a7d24 2026-05-28 Warnings Exact identifier application number: M020 TIZO ULTRA NON TINTED MINERAL SUNSCREEN ZINC OXIDE 20% Fallien Cosmeceuticals, LTD 30d30610-2e6c-418c-bbcf-4ecd7f61be93 2026-05-28 Warnings Exact identifier application number: M020 Creme Foundation ZINC OXIDE Lauren Brooke Cosmetiques LLC 4d09907e-ddcd-9d62-e063-6394a90acf3f 2026-05-28 Warnings Exact identifier application number: M020 GOONGBE Moisture Sun Cushion Mild SPF 50 ZINC OXIDE Zero to Seven Inc. 1e8720b4-5e8b-dc8b-e063-6394a90aad34 2026-05-27 Warnings Exact identifier application number: M020 GOONGBE Fresh Sun Stick Mild SPF 50 ZINC OXIDE Zero to Seven Inc. 1e8727a4-0dc0-19dc-e063-6394a90a82b6 2026-05-27 Warnings Exact identifier application number: M020 Tallow and Sol SUNSCREEN SPF30 NON-NANO ZINC OXIDE 20% Guangzhou Shengyanghui Industrial Trading Co., Ltd 52c9dc0a-41f7-3e8a-e063-6394a90a8fca 2026-05-27 Warnings Exact identifier application number: M020 Tallow and SolSUNSCREEN SPF50 NON-NANO ZINC OXIDE 25% Guangzhou Shengyanghui Industrial Trading Co., Ltd 52cb56cf-f092-9f86-e063-6394a90ac2d3 2026-05-27 Warnings Exact identifier application number: M020 SPF 50 Mineral Sunscreen Face and Body ZINC OXIDE Toddle Born Wild, Inc. e97d82fe-cd45-43a5-9c1f-3900025240a1 2026-05-27 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