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 82 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Blue Lizard Kids SPF 50 ZINC OXIDE Crown Laboratories 9983563c-1e63-0748-e053-2a95a90a971e 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Baby SPF 50 ZINC OXIDE Crown Laboratories 9948f5b8-43bd-1c99-e053-2a95a90a6121 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Sheer SPF 50 Sunscreen ZINC OXIDE Crown Laboratories 3368f1cb-c341-e886-e063-6394a90a9b7c 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Sport SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories 2f3844d8-0367-aad9-e063-6294a90a1fce 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Sheer Face SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories 30cd79da-2f25-a42a-e063-6394a90a8332 2026-01-12 Warnings Exact identifier application number: M020 ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREEN TITAMIUN DIOXIDE, ZINC OXIDE UCL Co., Ltd. 4837b4f6-ada9-801a-e063-6294a90a8547 2026-01-12 Warnings Exact identifier application number: M020 Intellishade Original SPF 45 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE Revision, LLC e213a681-eb22-69c0-e053-2995a90a899e 2026-01-12 Warnings Exact identifier application number: M020 GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASE HOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDE ORIGINS NATURAL RESOURCES INC. 48393640-4b97-04de-e063-6294a90aa6a6 2026-01-12 Warnings Exact identifier application number: M020 Hale and Hush Broad Spectrum SPF 30 SPF 30 ZINC OXIDE Eclectic Solutions LLC 0530904f-b02c-d8cf-e063-6294a90aa5a7 2026-01-12 Warnings Exact identifier application number: M020 Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Minori Inc. 1d4e2654-1638-0d01-e063-6394a90af303 2026-01-12 Warnings Exact identifier application number: M020 LUXURY BODY RITUAL HYDRATING SPF 30 ZINC OXIDE JANE STREET LLC 15e9d688-f226-1a19-e063-6394a90ab906 2026-01-12 Warnings Exact identifier application number: M020 BROAD SPECTRUM SPF50 SPF 50 AVOBENZONE, HOMOSALATE OCTISALATE, NAKED SUNDAYS PTY LTD 0426b1e9-063b-c1e6-e063-6294a90a2554 2026-01-11 Warnings Exact identifier application number: M020 SPF30 MINERAL SUNSCREEN MOUSSE ZINC OXIDE Aopline Biotechnology (Guangzhou) Co., Ltd. 48031a0f-c2ed-5424-e063-6294a90ad0ff 2026-01-10 Warnings Exact identifier application number: M020 SPF 30 MINERAL WHIPPED CREAMS SHIMMER ZINC OXIDE Aopline Biotechnology (Guangzhou) Co., Ltd. 48037a05-722e-4231-e063-6294a90ac51f 2026-01-10 Warnings Exact identifier application number: M020 ODLUMIVIE Tinted Mineral Sunscreen ZINC OXIDE,TITANIUM DIOXIDE Guangzhou Meijiao Medical Biotechnology Co., Ltd. 480d6e65-f6dc-d2a5-e063-6294a90a24a1 2026-01-10 Warnings Exact identifier application number: M020 Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE FUTURE 8 LLC 9922f132-f6a5-41ca-847a-936b20bf1716 2026-01-09 Warnings Exact identifier application number: M020 Sunscreen Lotion118mL ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4% Foshan Sugar Max Cosmetics CO.,Ltd 46355437-4068-9d03-e063-6394a90ae52c 2026-01-09 Warnings Exact identifier application number: M020 ST MORIZ SUNCARE FACE SUNSCREEN SPF30 SUNCARE FACE SUNSCREEN SPF30 Aopline Biotechnology (Guangzhou) Co., Ltd. 47f26af6-4d02-3506-e063-6294a90a0fe6 2026-01-09 Warnings Exact identifier application number: M020 Dr. C. Tuna Sun 6 SPF Tan and Care Carrot OCTINOXATE Farmasi US LLC 67de9257-70f3-4444-a4a2-a8d7425fcc0e 2026-01-09 Warnings Exact identifier application number: M020 Dr. C. Tuna Sunscreen SPF30 Broad Spectrum AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE Farmasi US LLC d9197dce-20a3-4d10-807c-ec84ab902165 2026-01-09 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