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 78 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior e4dbfd77-0eec-4d1a-94d6-4daca096d8c7 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 72569958-cd7d-4d52-add4-2b13706e1b1e 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 0f5aa600-4168-419b-95d7-569764b5f0b9 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior e5ab0cd9-ae7f-4558-b5ab-e0b582677224 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b9fa3bb9-12ec-40d8-b433-a96d9d00cc90 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f7b2e348-2c7f-4ff5-8ab0-a3475c9d1f26 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 69924eb8-a8ca-4ea0-b087-c865a6a1313f 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5cafac21-fb2d-4d63-a7fe-01bf53b941e8 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior bfc27e8d-e59b-46f7-aec9-2a96a00a7c1c 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 8fd56c86-ef37-4f31-87d1-6283a19c8424 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 91b62ba7-2deb-47e6-b9af-25bb459b4d75 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6eec7554-38ed-48d4-916d-ab3660fbf703 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 939e6d5c-3dd7-4b01-af18-697dc4ba2d99 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 7149784b-3548-4643-abf6-58fde237bb98 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 061181d8-5387-4541-a7d7-426cba5997a0 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f6ad554a-4795-4149-b066-c53a0989470e 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 58efeaaf-d3c6-44e9-b60f-8f22f5bb1d33 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f6b4a90b-5905-4f62-9e35-f2b1dda8dddd 2026-01-16 Warnings Exact identifier application number: M020 Poolside Frostbite Sunscreen Watermelon SPF 15 Scented Lip Gloss HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE I World LLC 42c8fd50-73c6-480b-9d7e-31157e586929 2026-01-16 Warnings Exact identifier application number: M020 HYDRA VIZOR HUEZ TINTED MOISTURIZER BROAD SPECTRUM SPF 30 ZINC OXIDE KENDO HOLDINGS INC. 18fb7472-746f-339a-e063-6294a90a267d 2026-01-16 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