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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 18 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65753-603DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-01DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-02DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-03DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-04DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-05DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-07DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-09DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-10DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-22DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-23DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-24DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-25DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-26DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-32DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-33DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-34DDiscontinued by firm2026-10-23
excluded packagepackage65753-60365753-603-39DDiscontinued by firm2026-10-23

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-33d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-23d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-39d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-26d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-26d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-23d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-34d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-32d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-22d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65753-603-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-33f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-23f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-39f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-26f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-26f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-23f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-34f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-32f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-22f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65753-603-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-332ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-232ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-392ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-262ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-262ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-232ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-342ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-322ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-222ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65753-603-242ef7874e63bc…57b86245f4fa…

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
IngredientStrength
HOMOSALATE10 g/100mL
OCTOCRYLENE5 g/100mL
OCTISALATE5 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f67a6c6c-c314-1c9d-e053-2a95a90a7f1aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-603-01CorTex SunX 50 Thick30 mL in 1 BOTTLELOTION306
65753-603-02CorTex SunX 50 Thick60 mL in 1 BOTTLELOTION606
65753-603-03CorTex SunX 50 Thick120 mL in 1 BOTTLELOTION1206
65753-603-04CorTex SunX 50 Thick177 mL in 1 BOTTLELOTION1776
65753-603-05CorTex SunX 50 Thick237 mL in 1 BOTTLELOTION2376
65753-603-07CorTex SunX 50 Thick473 mL in 1 BOTTLELOTION4736
65753-603-08CorTex SunX 50 Thick762 mL in 1 BOTTLE, DISPENSINGLOTION7626
65753-603-09CorTex SunX 50 Thick960 mL in 1 BOTTLELOTION9606
65753-603-10CorTex SunX 50 Thick3800 mL in 1 BOTTLELOTION38006
65753-603-22CorTex SunX 50 Thick25 in 1 CONTAINERLOTION256
65753-603-23CorTex SunX 50 Thick25 in 1 CONTAINERLOTION256
65753-603-24CorTex SunX 50 Thick50 in 1 CONTAINERLOTION506
65753-603-25CorTex SunX 50 Thick100 in 1 CONTAINERLOTION1006
65753-603-26CorTex SunX 50 Thick150 in 1 CARTONLOTION1506
65753-603-32CorTex SunX 50 Thick44 mL in 1 BOTTLELOTION446
65753-603-33CorTex SunX 50 Thick60 mL in 1 BOTTLELOTION606
65753-603-34CorTex SunX 50 Thick120 mL in 1 BOTTLELOTION1206
65753-603-35CorTex SunX 50 Thick762 mL in 1 BOTTLELOTION7626
65753-603-39CorTex SunX 50 Thick7 mL in 1 POUCHLOTION76

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-603CORTEX SUNX 50 THICK (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CORETEX PRODUCTS INC]5Current NDC, 19 package rows20250209_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 96 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inccc5dafd4-dfd4-d310-e053-2995a90a82a82025-12-31WarningsExact identifier
application number: M020
Coppertone EveryTone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Inc04c58384-fd82-f6d0-e063-6294a90a3ff12025-12-31WarningsExact identifier
application number: M020
Coppertone Sport SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdort Inccc46b3a3-48f5-4593-e053-2995a90a87822025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sport SPF 60 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23fb7304-789d-1f94-e063-6394a90a7e622025-12-31WarningsExact identifier
application number: M020
Coppertone Kids SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccbf9a785-f218-76fb-e053-2995a90a8e032025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60c2a38-ef92-0dff-e053-2995a90a47c42025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30(TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a5370-ec6f-42a7-e063-6394a90ac37c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd53e1253-f6a4-4f3d-e053-2a95a90a79ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Face SPF 60 Plus SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc04b36eb1-bffc-c31e-e063-6294a90a8eb32025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd47460a1-4768-ee44-e053-2a95a90adecf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50ZINC OXIDE 20%Beiersdorf Incd46359e7-b585-c43a-e053-2995a90a08632025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd473e7ed-4a9f-76fe-e053-2995a90ab37d2025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incf3e3f4c6-2cb9-7b17-e053-2a95a90a38542025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Age Defense Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23f88c88-b68e-4706-e063-6294a90afb382025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd473113d-2fc3-6b1c-e053-2a95a90a88ed2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Incd89df7a5-7741-3e1d-e053-2995a90ae2752025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd475e14f-dab1-dec5-e053-2995a90aef732025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd4757d99-bac6-48fb-e053-2a95a90ab1bf2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc24d3fbbc-0bce-b47a-e063-6394a90a9afa2025-12-31WarningsExact identifier
application number: M020
Sei Bella CC Brightening Creme LightOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6894b9d9-a5b5-4c98-e053-2991aa0a9ca22025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65753-603-016575306030130 mL in 1 BOTTLE (65753-603-01) 30 ml2023-03-09NoNoCurrent
65753-603-026575306030260 mL in 1 BOTTLE (65753-603-02) 60 ml2023-03-09NoNoCurrent
65753-603-0365753060303120 mL in 1 BOTTLE (65753-603-03) 120 ml2023-03-09NoNoCurrent
65753-603-0465753060304177 mL in 1 BOTTLE (65753-603-04) 177 ml2023-03-09NoNoCurrent
65753-603-0565753060305237 mL in 1 BOTTLE (65753-603-05) 237 ml2023-03-09NoNoCurrent
65753-603-0765753060307473 mL in 1 BOTTLE (65753-603-07) 473 ml2023-03-09NoNoCurrent
65753-603-0865753060308762 mL in 1 BOTTLE, DISPENSING (65753-603-08) 762 ml2023-03-09NoNoCurrent
65753-603-0965753060309960 mL in 1 BOTTLE (65753-603-09) 960 ml2023-03-09NoNoCurrent
65753-603-10657530603103800 mL in 1 BOTTLE (65753-603-10) 3800 ml2023-03-09NoNoCurrent
65753-603-226575306032225 POUCH in 1 CONTAINER (65753-603-22) / 7 mL in 1 POUCH (65753-603-39) 25 pouch2023-03-09NoNoCurrent
65753-603-236575306032325 POUCH in 1 CONTAINER (65753-603-23) / 7 mL in 1 POUCH (65753-603-39) 25 pouch2023-03-09NoNoCurrent
65753-603-246575306032450 POUCH in 1 CONTAINER (65753-603-24) / 7 mL in 1 POUCH (65753-603-39) 50 pouch2023-03-09NoNoCurrent
65753-603-2565753060325100 POUCH in 1 CONTAINER (65753-603-25) / 7 mL in 1 POUCH (65753-603-39) 100 pouch2023-03-09NoNoCurrent
65753-603-2665753060326150 POUCH in 1 CARTON (65753-603-26) / 7 mL in 1 POUCH (65753-603-39) 150 pouch2023-03-09NoNoCurrent
65753-603-326575306033244 mL in 1 BOTTLE (65753-603-32) 44 ml2023-03-09NoNoCurrent
65753-603-336575306033360 mL in 1 BOTTLE (65753-603-33) 60 ml2023-03-09NoNoCurrent
65753-603-3465753060334120 mL in 1 BOTTLE (65753-603-34) 120 ml2023-03-09NoNoCurrent
65753-603-3565753060335762 mL in 1 BOTTLE (65753-603-35) 762 ml2023-03-09NoNoCurrent
65753-603-39657530603397 mL in 1 POUCH (65753-603-39) 7 ml2023-03-09NoNoCurrent