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 104 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6da72e20-f2d7-492e-9b65-b5ac73bc0029 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior de615c3e-669f-493c-9c75-73dfbe726c59 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 152790ba-aeda-4c2a-b725-7e040e832883 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c87e5201-f7fd-4fd9-adeb-d6af9be00db6 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 84cdaad2-5b7d-4841-bef6-ffad4fe6907a 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00 OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b4caa2bc-8118-4137-8834-25800f8e5e01 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c0fa32fe-faa7-4a47-906c-14db01e55d47 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 8N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ff1a8b32-c01f-4910-9a7a-c74eb49c05a0 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior d3bd710b-7d1a-4f96-9fbc-a67c550d863b 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 3b6ea0ec-4636-43cf-a324-a82666108e95 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5ac7fb96-a2f2-4086-82ad-c45d7a709091 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 84a5f7e1-1c04-43cd-8d3b-60c7e2418faf 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 28a61b11-5901-47ec-916c-e2ae4f79a11d 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5ddf8221-9bfc-4c52-9a51-a0d725b7a23e 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5937248a-b96e-490a-9f93-10e65969ac10 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 2cc7d9f6-f789-4f9b-91b7-73f9d0fee85c 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 62136c4c-6f05-4de0-a71e-55aa53160685 2025-12-19 Warnings Exact identifier application number: M020 FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a8037741-ec57-43e7-adb4-2a93941ee108 2025-12-19 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