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 87 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hawaiian Blend Sensitive Zinc SPF 50 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group b42261c5-fa6e-4bb3-93c0-97032ab9f716 2026-01-07 Warnings Exact identifier application number: M020 CabanaMilk Mineral Barrier Fluid SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 47d0fe4d-ad21-1004-e063-6394a90a9c19 2026-01-07 Warnings Exact identifier application number: M020 CENTELLA RELIEF SOOTHING SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE IUNIK Co., Ltd. 47d170e3-dd76-d413-e063-6294a90ae8e4 2026-01-07 Warnings Exact identifier application number: M020 Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum ZINC OXIDE SEORIN COMPANY Co., Ltd. 1e7cc417-3c57-c87c-e063-6394a90a670b 2026-01-07 Warnings Exact identifier application number: M020 Proactiv Clear Skin SPF 30 AVOBENZONE, OCTISALATE, AND OCTOCRYLENE Alchemee, LLC b0aa7ff0-f712-486f-aaaf-f88fed3b5cd1 2026-01-07 Warnings Exact identifier application number: M020 Daily Hydrating Mineral Body Sunscreen Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Oak Essentials, LLC 47d37f44-10b2-214f-e063-6294a90a5abc 2026-01-07 Warnings Exact identifier application number: M020 PLUMSCREEN SPF 31 ZINC OXIDE Le Prunier Farms, Inc. e20eb996-2b64-6bd0-e053-2a95a90a4f92 2026-01-07 Warnings Exact identifier application number: M020 BETA-GLUCAN MILD SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE IUNIK Co., Ltd 47d6ad8b-1081-ee21-e063-6294a90a0e63 2026-01-07 Warnings Exact identifier application number: M020 Koobarra Mineral Face Sunscreen SPF 50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 37cf8143-99f2-cca5-e063-6394a90a19a8 2026-01-07 Warnings Exact identifier application number: M020 Solar Swipe Mineral Sunscreen SPF50 SOLAR SWIPE MINERAL SUNSCREEN SPF50 Guangzhou Fantesy Biotechnology Co.,Ltd 47d75d61-5295-3eab-e063-6394a90a01c1 2026-01-07 Warnings Exact identifier application number: M020 LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREEN ZINC OXIDE JANE STREET LLC dbdd3e6a-f09d-90cf-e053-2a95a90a98a0 2026-01-07 Warnings Exact identifier application number: M020 RENEWALUXE SPF 50 Sunscreen RENEWALUXE SPF 50 SUNSCREEN Guangzhou Fantesy Biotechnology Co.,Ltd 1bc29960-5e73-e8ab-e063-6294a90a3f80 2026-01-06 Warnings Exact identifier application number: M020 ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN SPF50 Wild Child Laboratories PTY Ltd 2767ba3e-7434-d474-e063-6294a90aa4ff 2026-01-06 Warnings Exact identifier application number: M020 ULTRA VIOLETTE SPF ON THE GLOW Duo Pack Kit SPF 50 Grace And Fire USA Inc. 47b7da8a-ea89-1402-e063-6294a90a23f9 2026-01-06 Warnings Exact identifier application number: M020 Hawaiian Blend Essential Zinc SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group 5a6e622f-2c00-406a-8860-d7081656f597 2026-01-06 Warnings Exact identifier application number: M020 SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5 OCTINOXATE AND TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION 66c22f17-5418-42ff-97b2-33fa10f5eac3 2026-01-06 Warnings Exact identifier application number: M020 SHISEIDO BENEFIANCE WRINKLERESIST24 DAY AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE SHISEIDO AMERICAS CORPORATION 7d9c0f81-005f-4223-940e-a64143db5275 2026-01-06 Warnings Exact identifier application number: M020 SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMER TITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLE SHISEIDO AMERICAS CORPORATION ff088b0c-27c9-4ea8-bf94-6261378c7190 2026-01-06 Warnings Exact identifier application number: M020 Drs. pharmacy sunscreen SPF 50 (physical filters) SUNSCREEN SPF 50 OL PHARMA TECH LLC. (Drs. Pharmacy) 31e976a2-0623-0dca-e063-6394a90a08da 2026-01-06 Warnings Exact identifier application number: M020 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair Shirakaba OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION 26151cf4-0fee-4a42-92fd-4d7b9cef8381 2026-01-06 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