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 33 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Target Up and Up SPF 50 Coconut Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 51510195-a577-dce4-e063-6294a90a3e74 2026-05-08 Warnings Exact identifier application number: M020 Target Up and Up SPF 50 Watermelon Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 5151493a-c25a-fb59-e063-6394a90a1034 2026-05-08 Warnings Exact identifier application number: M020 Target Up and Up SPF 50 Strawberry Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 51512b9f-514d-3a29-e063-6294a90ae173 2026-05-08 Warnings Exact identifier application number: M020 Target Up and Up SPF 50 Peony Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 5151560f-350c-88c3-e063-6294a90a3492 2026-05-08 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior bb65c8d7-318f-4d52-9d74-ca22ce389638 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Cassette CIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTE LE COSMETICS INC 5139cc37-62ac-514b-e063-6394a90a9ca3 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Kelly CIELE LIP AND PROTECT LIPSTICK SPF 60 KELLY LE COSMETICS INC 5139d3c1-83d1-2ad9-e063-6394a90a6958 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Margaux CIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUX LE COSMETICS INC 5138eb74-0223-6c1f-e063-6294a90a3bc6 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Bonnie CIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIE LE COSMETICS INC 513a0449-5494-5dfd-e063-6394a90a026e 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 LouLou CIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOU LE COSMETICS INC 5139dab1-3c27-a59e-e063-6294a90a7096 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Puzzle CIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLE LE COSMETICS INC 513a0722-42ab-1051-e063-6294a90a8a1d 2026-05-07 Warnings Exact identifier application number: M020 Ciele lip and PROTECT lipstick SPF 60 Saddle CIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLE LE COSMETICS INC 513a12cf-0230-6a24-e063-6394a90afb95 2026-05-07 Warnings Exact identifier application number: M020 Target Up and Up SPF 50 Banana Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 513bdfb1-6b90-dfc7-e063-6394a90a9ec2 2026-05-07 Warnings Exact identifier application number: M020 Zinc Oxide 20.00% SPF 50 MINERAL Coconut Caliente Costa Rica LLC 388f1e01-0feb-4c94-88a7-13c81368c6c8 2026-05-07 Warnings Exact identifier application number: M020 SPF 50 Kids Sunscreen HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3% Coconut Caliente Costa Rica LLC 9839570f-eeef-4140-a6ca-9fd2c9767a5b 2026-05-07 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 67b90f00-4c82-40cd-af96-f8dedf95f8af 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 7a2bd17d-0ea7-4326-9939-a747869c01d2 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a396c0eb-f91f-4732-9c20-6b25aa0634b7 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 18b21fba-f6ee-4ac5-a536-096716f51da0 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 13c34bba-f939-4aa7-9457-9d6025902e06 2026-05-06 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