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 100 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium Tan HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47387d5f-e77b-5633-e063-6294a90a5584 2025-12-30 Warnings Exact identifier application number: M020 Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4738be66-0fe8-148e-e063-6394a90a1b02 2025-12-30 Warnings Exact identifier application number: M020 Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan Deep HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4738eed1-9f72-5fd8-e063-6394a90a26bd 2025-12-30 Warnings Exact identifier application number: M020 Ageless Glow Serum BB Cream Sunscreen SPF 40 - Deep HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4739179e-88b3-8820-e063-6394a90aa211 2025-12-30 Warnings Exact identifier application number: M020 WHITE TEA TINTED MOISTURIZER WHITE TEA TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN GLOW CONCEPT INC eb2df93f-6cdc-7ae8-e053-2a95a90a0091 2025-12-29 Warnings Exact identifier application number: M020 Hawaiian Natural Zinc Sunscreen SPF 50 ZINC OXIDE Kokua Sun Care 64a5589b-735d-38ba-e053-2a91aa0ad8f4 2025-12-29 Warnings Exact identifier application number: M020 Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30 ZINC OXIDE Kokua Sun Care f9a12dac-2fd0-798f-e053-6394a90aa784 2025-12-29 Warnings Exact identifier application number: M020 Calming Days Vegan Sunscreen ,OCTYL TRIAZONE (ETHYLHEXYL TRIAZONE), BISOCTRIZOLE, DIETHYLHEXYL BUTAMIDO TRIAZONE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE MERCYCO Co., Ltd. 38898014-eefe-73ec-e063-6394a90a3738 2025-12-29 Warnings Exact identifier application number: M020 SPF 30 Sunscreen ZINC OXIDE, TITANIUM DIOXIDE CLEURE f5512f34-08ee-b0f6-e053-2a95a90ab5bd 2025-12-29 Warnings Exact identifier application number: M020 COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 20 SUNSCREEN OIL Soleil Collective LLC 471b3028-2c13-ab70-e063-6394a90aa660 2025-12-29 Warnings Exact identifier application number: M020 COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 45 SUNSCREEN OIL Soleil Collective LLC 471c0eed-f7ca-3c3b-e063-6294a90ad2c6 2025-12-29 Warnings Exact identifier application number: M020 EIGHT HOUR NOURISHING LIP SPF 20 OCTINOXATE, AVOBENZONE REVLON b3c16e60-752d-6eba-e053-2995a90a2b20 2025-12-29 Warnings Exact identifier application number: M020 CERAMIDE PREMIERE BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE REVLON b3358bfd-7fe5-33e2-e053-2a95a90ac2ea 2025-12-29 Warnings Exact identifier application number: M020 Prevage anti aging SPF 30 OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE, Revlon b2bff796-1579-2686-e053-2995a90ad6c7 2025-12-29 Warnings Exact identifier application number: M020 FLAWLESS FUTURE SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, AVAOBENZONE REVLON b553aec1-5002-3a3f-e053-2995a90a22e5 2025-12-29 Warnings Exact identifier application number: M020 Prevage Anti-aging eye cream SPF 15 OCTINOXATE, OXYBENZONE Revlon b2a92d72-e634-7379-e053-2995a90a2bca 2025-12-29 Warnings Exact identifier application number: M020 Prevage Anti-aging Moisture Cream OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE Revlon Consumer Products Corp b247adbe-dfe8-df0a-e053-2995a90a34d9 2025-12-29 Warnings Exact identifier application number: M020 Sheer Protection SPF 30 ZINC OXIDE Skin Script, LLC 0450dcc9-3f8f-e2c2-e063-6294a90af60b 2025-12-29 Warnings Exact identifier application number: M020 RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20 OCTINOXATE AND TITANIUM DIOXIDE ESTEE LAUDER INC 897b8edb-f089-4a49-baca-e05806b0a068 2025-12-29 Warnings Exact identifier application number: M020 Mine Line Coconut Sunscreen SPF 50 ZINC OXIDE Spa de Soleil 4642b1cc-43b1-6997-e063-6394a90ac764 2025-12-29 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