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 73 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 310a07bb-d32a-401f-955e-4c2860148a30 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 39ae4a97-7f96-4c95-a6de-0c779764fb02 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922fc3e-055c-e51d-e063-6294a90a00f5 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 9c7a31df-5bdd-403b-b807-1d1a801e1bb6 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922fc51-ae53-acb8-e063-6394a90a14eb 2026-01-20 Warnings Exact identifier application number: M020 Wrinkle Repair Moisturizer SPF 30 EQB AVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2% Walmart a067e968-e598-40ef-95f2-c338b5e413dd 2026-01-20 Warnings Exact identifier application number: M020 Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Welmedix LLC 48da4589-0f5a-c25b-e063-6394a90ac18b 2026-01-20 Warnings Exact identifier application number: M020 SPF 50 Mineral Sunscreen Kids ZINC OXIDE 14.69% S&C Hampton Sun LLC 0bdb7d15-dc52-4e23-9417-fe73f17f6110 2026-01-20 Warnings Exact identifier application number: M020 DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICK OCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATE DEWYTREE CO. ,LTD 48406e68-eefd-d2c2-e063-6394a90a4ad9 2026-01-20 Warnings Exact identifier application number: M020 KONEUK SUNSCREEN SPF50 KONEUK SUNSCREEN SPF50 Guangzhou Meixi Biotechnology Co., Ltd. 48dd7f6e-2a4d-2c92-e063-6294a90a4255 2026-01-20 Warnings Exact identifier application number: M020 CHUDA AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE Premier Ocher LLC 1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f 2026-01-20 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 12edec55-2414-4bbd-bc96-4599a96b96ac 2026-01-19 Warnings Exact identifier application number: M020 PROJECT REEF SPF-30 Mineral Sunscreen ZINC OXIDE Project Reef LLC a6077e6f-d987-4159-946f-3e2397247659 2026-01-19 Warnings Exact identifier application number: M020 OUTER REEF MINERAL SUNSCREEN SPF 30 TITANIUM DIOXIDE Coral Reef Park Co., Inc. 86ee2fdf-8a88-44e6-b12a-36a92360477a 2026-01-19 Warnings Exact identifier application number: M020 SABAL Mineral Sunscreen Broad Sprectrum SPF 30 ZINC OXIDE SABAL SUN LLC f917b446-4e10-4231-826e-fdac32e11186 2026-01-19 Warnings Exact identifier application number: M020 Plius Daily SPF Moisturizer SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE PLIUS, Inc 31866de9-afa0-4c11-be65-b61373551493 2026-01-19 Warnings Exact identifier application number: M020 PROTEKT SPF-50 Sheer Mineral Sunscreen ZINC OXIDE Protekt Products, Inc. 6edc0941-bb21-4797-a875-81f727694774 2026-01-19 Warnings Exact identifier application number: M020 Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21) ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20% Grace and Fire USA Inc. 48c1b93c-9c6f-95aa-e063-6294a90a0cfa 2026-01-19 Warnings Exact identifier application number: M020 ANUA INVISIBLE GLOW FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 446ac344-1078-4cd1-e063-6294a90a4bd4 2026-01-19 Warnings Exact identifier application number: M020 ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 31af7b5e-2bd6-63ee-e063-6294a90a0806 2026-01-19 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