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 83 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr. C. Tuna Lumi Radiance Brightening OCTOCRYLENE, OCTINOXATE, AVOBENZONE Farmasi US LLC adf5621b-7cf0-53b3-e053-2a95a90a8058 2026-01-09 Warnings Exact identifier application number: M020 Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15 HOMOSALATE, OCTINOXATE FARMASI US LLC 1dbd5e83-2248-4751-88d9-b446ccc3c61e 2026-01-09 Warnings Exact identifier application number: M020 Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body Sun AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE Farmasi US LLC 27fdbd2b-60de-4906-a176-5c5198d9925b 2026-01-09 Warnings Exact identifier application number: M020 Skin Metal Stealth ZINC OXIDE Skin Metal 47f5d7de-5d32-041a-e063-6394a90ab6f9 2026-01-09 Warnings Exact identifier application number: M020 Salt and Blue Body Sunscreen SPF 30 ZINC OXIDE 20% Salt + Blue LLC 47f764a0-e9ad-ef66-e063-6394a90a8de5 2026-01-09 Warnings Exact identifier application number: M020 City Sunscreen serum Broad Spectrum SPF 30 Supergoop HOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENE Supergoop, LLC 61766f7b-512d-45b5-b652-e09975a3d3fc 2026-01-09 Warnings Exact identifier application number: M020 Defense Refresh (Re)Setting Mist SPF 40 AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENE Supergoop LLC b95ad8e3-978b-b721-e053-2a95a90a1e54 2026-01-09 Warnings Exact identifier application number: M020 Daily Dose Vitamin C and Broad Spectrum SPF 40 Serum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC aed0dd03-1695-a5a9-e053-2995a90acfdc 2026-01-09 Warnings Exact identifier application number: M020 Hand Screen Broad Spectrum Sunscreen SPF 40 AVOBENZONE, OCTISALATE, OCTOCRYLENE Supergoop, LLC 972ebab9-3f2f-6716-e053-2a95a90a5c75 2026-01-09 Warnings Exact identifier application number: M020 Glow Oil Broad Spectrum Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop, LLC 972c68e7-b137-34c6-e053-2a95a90a77d6 2026-01-09 Warnings Exact identifier application number: M020 Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip Gloss HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE I World LLC ee045b64-7a95-4378-8183-e6e556f3b184 2026-01-09 Warnings Exact identifier application number: M020 Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE I World LLC 967d0657-18fc-4e4a-b52d-442df43329f1 2026-01-09 Warnings Exact identifier application number: M020 PLAY SPF 30 Lip Shield Coconut AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop, LLC b0b8b850-bdfe-5563-e053-2995a90a51a7 2026-01-09 Warnings Exact identifier application number: M020 Play SPF 30 Lip Shield Strawberry AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop, LLC b0a49142-53c3-5b7a-e053-2995a90a581d 2026-01-09 Warnings Exact identifier application number: M020 Glow Stick Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Supergoop, LLC 61e543e3-9ace-6440-e053-2991aa0a9647 2026-01-09 Warnings Exact identifier application number: M020 (RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35 ZINC OXIDE Supergoop, LLC af5c9801-26ce-5c60-e053-2995a90ab457 2026-01-09 Warnings Exact identifier application number: M020 (Re) Setting 100% mineral Powder Light Broad Spectrum SPF 35 ZINC OXIDE Supergoop, LLC aed5a7ef-5cf2-6738-e053-2a95a90aa7f7 2026-01-09 Warnings Exact identifier application number: M020 Play Mineral Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Supergoop, LLC 89088ac5-f1ee-1996-e053-2a95a90a8fdc 2026-01-09 Warnings Exact identifier application number: M020 (RE) Setting 100% Mineral Powder Medium Broad Spectrum Sunscreen SPF 35 ZINC OXIDE Supergoop, LLC af4b0f17-43ec-a176-e053-2a95a90a7ac6 2026-01-09 Warnings Exact identifier application number: M020 (Re) Setting 100% mineral Powder Deep Broad Spectrum SPF 35 ZINC OXIDE Supergoop, LLC af4cb85b-1275-2105-e053-2995a90a7e74 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