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 90 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SHISEIDO ULTIMATE SUN PROTECTOR OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDE SHISEIDO AMERICAS CORPORATION c656792a-e1ed-478d-b501-9bdc92d16eca 2026-01-05 Warnings Exact identifier application number: M020 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTER OCTINOXATE AND TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION 0a214b6b-69a7-4cb9-9095-6fcf2b6945de 2026-01-05 Warnings Exact identifier application number: M020 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR OCTINOXATE AND TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION fb6ac681-ff74-4420-a4f6-843d5f2b6d6b 2026-01-05 Warnings Exact identifier application number: M020 CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE SHISEIDO AMERICAS CORPORATION 207e2035-5f31-4745-a801-b386b040b738 2026-01-05 Warnings Exact identifier application number: M020 Hawaiian Blend Essential Zinc SPF 50 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group 47aa8605-e536-b998-e063-6394a90ad9f0 2026-01-05 Warnings Exact identifier application number: M020 SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT OCTINOXATE AND TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION bf736c5b-fc33-4cd5-8d18-03929f739d76 2026-01-05 Warnings Exact identifier application number: M020 SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1 OCTINOXATE SHISEIDO AMERICAS CORPORATION 8a9294c2-3933-4f9c-b7e6-1f446f441a16 2026-01-05 Warnings Exact identifier application number: M020 Shiseido Future Solution LX Total Protective AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE SHISEIDO AMERICAS CORPORATION 6de17911-4bce-46c9-906b-07d899a36ceb 2026-01-05 Warnings Exact identifier application number: M020 CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORY OCTINOXATE AND TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION c4028089-677f-4d51-9c8b-3892ff1649e0 2026-01-05 Warnings Exact identifier application number: M020 SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110 OCTINOXATE AND TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION 8a0da327-a805-4ef9-b69a-14bf7278a81a 2026-01-05 Warnings Exact identifier application number: M020 CLE DE PEAU BEAUTE CORRECTING VEIL n ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION fd9b42e4-6f9d-45a9-bee3-ac1bc4b35252 2026-01-05 Warnings Exact identifier application number: M020 SHISEIDO THE MAKEUP FOUNDATION I20 TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION 3c024fe9-2983-4857-a55a-13406158e3a9 2026-01-05 Warnings Exact identifier application number: M020 cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10 TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION b2b55a7a-1f68-429d-ba70-5bb6c7e0d8d3 2026-01-05 Warnings Exact identifier application number: M020 HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY ZINC OXIDE Kao USA Inc. 26bcb9cd-bfb5-998c-e063-6394a90ab9d6 2026-01-05 Warnings Exact identifier application number: M020 HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD ZINC OXIDE Kao USA Inc. 26cf1320-aae5-2ea0-e063-6394a90a3be2 2026-01-05 Warnings Exact identifier application number: M020 OZE SUN BONDI ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 47b1aae6-0b86-7d48-e063-6294a90a9ece 2026-01-05 Warnings Exact identifier application number: M020 Hybrid SPF SPF 30 OCTOCRYLENE, OCTISALATE, ZINC OXIDE Topiderm, Inc. 5c99f98c-025c-4886-824f-af968033baf4 2026-01-05 Warnings Exact identifier application number: M020 TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 Plus TITANIUM DIOXIDE HEY HONEY INC. 21187805-fae9-476c-81b0-27ffeb0b9911 2026-01-05 Warnings Exact identifier application number: M020 VEAKSON BEEF TALLOW SUNSCREEN ZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACID Guangdong Aimu Biological Technology Co., Ltd 473c241a-1258-1680-e063-6394a90a7d98 2026-01-04 Warnings Exact identifier application number: M020 HYDRATING SUNSCREEN HYDRATING SUNSCREEN Guangzhou Yapeng Refinement Chemical Co., Ltd. 19a3687b-32b0-7c83-e063-6294a90aaf81 2026-01-04 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