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 93 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coppertone Pure and Simple Baby Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 08134b95-1879-27e5-e063-6294a90a29af 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Oil Free SPF 50 Sunscreen AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8% Beiersdorf Inc ded1f158-36d1-153f-e053-2995a90ace30 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Pure and Simple Kids Suncreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 08147940-0e8b-c894-e063-6394a90af8ac 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Sport Sunscreen SPF 70 AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% Beiersdorf Inc e468d703-fa6c-095a-e053-2a95a90a5194 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 0806bdb9-961f-3146-e063-6294a90a4625 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Sport Sunscreen SPL 15 AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% Beiersdorf Inc df4b522e-93d4-1284-e053-2a95a90a1cd9 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Pure and Simple Baby Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 088b7152-d3d1-9e74-e063-6394a90a4152 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Sport Sunscreen SPF 50 (TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5% Beiersdorf Inc 0a5a40ff-a014-3995-e063-6394a90a11e6 2025-12-31 Warnings Exact identifier application number: M020 Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Deep OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47461ad3-a11e-2a11-e063-6294a90a0f8f 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Oil Free Sunscreen SPF 30 AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6% Beiersdorf Inc e451ecfb-cf17-c622-e053-2a95a90a4d4b 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Pure and Simple Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 081484f8-58f5-f2a4-e063-6394a90a3379 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Pure and Simple Kids Sunscreen SPF 50 ZINC OXIDE (24.08%) Beiersdorf Inc 09a97e3f-f6dc-eaa7-e063-6294a90ad274 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Kids Roll-On Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc f3e1ea21-4a07-3e18-e053-2995a90a0fe7 2025-12-31 Warnings Exact identifier application number: M020 Eucerin Sensitive Mineral Face Sunscreen SPF 35 ZINC OXIDE 24% Beiersdorf Inc f3a8bb6b-f051-5d39-e053-2a95a90adafc 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Limited Edition Sunscreen SPF 30 AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% Beiersdorf Inc f41e09bf-407d-65a4-e053-2a95a90a2436 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Glow Hydragel SPF 50 AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% Beiersdort Inc b5f7cacb-92b9-a6b7-e053-2a95a90aea02 2025-12-31 Warnings Exact identifier application number: M020 Eucerin Advanced Hydration Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Beiersdorf Inc cd6112fe-89e4-a79b-e053-2a95a90ad7f4 2025-12-31 Warnings Exact identifier application number: M020 Eucerin Age Defense SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Beiersdort Inc cd9d4f30-fb37-9935-e053-2995a90a9936 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Sport Sunscreen SPF 70 AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% Beiersdorf Inc cc5d1f9b-2c8a-1392-e053-2a95a90acb9e 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Every Tone Brightening Sunscreen SPF 60 AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% Beiersdorf Inc 23e368db-4b2f-d23b-e063-6394a90a1f06 2025-12-31 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