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 72 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sky and Sol Face and Body Sunscreen Spf 30 ZINC OXIDE Delta Ecommerce LLC 47dbcf07-7e3a-e3de-e063-6294a90a2c21 2026-01-21 Warnings Exact identifier application number: M020 sunscreen TITANIUM DIOXIDE Guangdong Zhoubang Biotechnology Co., Ltd 48f13b1c-8104-881b-e063-6394a90a816d 2026-01-21 Warnings Exact identifier application number: M020 Sunscreen lip balm ETHYLHEXYL SALICYLATE Guangdong Zhoubang Biotechnology Co., Ltd 48f1ee5c-33d0-818c-e063-6294a90a1e59 2026-01-21 Warnings Exact identifier application number: M020 Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen Mother CEILE SPF 30 PRIME PROTECT RADIATE MOTHER LE COSMETICS INC 490db6ef-d7f2-446c-e063-6294a90af303 2026-01-21 Warnings Exact identifier application number: M020 DewyVita Zero Spot Sunscreen OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE BAREUNPLAN CO.,LTD. 497c98c3-d809-52e0-e063-6294a90acca2 2026-01-21 Warnings Exact identifier application number: M020 Mario Badescu The Moisture Magnet SPF 15 OCTINOXATE, OXYBENZONE, AVOBENZONE Bentley Laboratories LLC 4c0b4733-96ea-4b1d-8a7b-13af66cc28d0 2026-01-21 Warnings Exact identifier application number: M020 Sensitif Renewal Cream Daily Protection SPF 30 Broad Spectrum UVA UVB Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE RV Skincare LLC 86b46c9b-6573-439b-b38b-2d76d495df6d 2026-01-20 Warnings Exact identifier application number: M020 Perfectif Even Skin Tone Cream Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE RV Skincare LLC 1b8cf189-0d06-4e86-bd7b-b77a638f1670 2026-01-20 Warnings Exact identifier application number: M020 Bella s Friends SPF50 Sunscreen ZINC OXIDE PANERGYTEKUSAINC 48ce4ef7-e24a-4894-e063-6294a90a49c8 2026-01-20 Warnings Exact identifier application number: M020 Christian Dior Invisible UV Fluid with Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Parfums Christian Dior 93a27f09-14e2-47a0-ac5f-4d3425e31ec9 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Ten ZINC OXIDE Clean Beauty For All, Inc (dba Saie) d00b978d-1682-4cde-ae5f-189e677136c4 2026-01-20 Warnings Exact identifier application number: M020 Saie Sunvisor Broad Spectrum SPF 35 Sheer Moisturizer ZINC OXIDE Clean Beauty For All, Inc b6bfd636-2f46-3fca-e053-2a95a90a05a6 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwo ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 19230647-29a3-d209-e063-6394a90aae36 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 8e2a2046-13e6-4a40-a0bc-65c979c59b93 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Eight ZINC OXIDE Clean Beauty For All, Inc (dba Saie) dbc4242a-3651-48be-bfc6-c595be5a2a15 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922f11d-10ce-82b4-e063-6394a90a6650 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922e001-e699-7ac5-e063-6394a90a25d9 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Six ZINC OXIDE Clean Beauty For All, Inc (dba Saie) a9350360-7932-459f-806c-399fa265e6c0 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1923067f-1ab9-d168-e063-6394a90adbd0 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922ee84-d7d0-80b1-e063-6394a90acf7b 2026-01-20 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