FDA.reportPublic FDA data

CorTex SunX 50 Thick

Product NDC
65753-602
11-digit product format
657530602
Labeler code
65753
Product ID
65753-602_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/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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/100g
OCTOCRYLENE5 g/100g
OCTISALATE5 g/100g
AVOBENZONE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal 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
65753-602-22CorTex SunX 50 Thick25 in 1 CONTAINERLOTION256
65753-602-22CorTex SunX 50 Thick7 g in 1 POUCHLOTION76
65753-602-23CorTex SunX 50 Thick7 g in 1 POUCHLOTION76
65753-602-23CorTex SunX 50 Thick25 in 1 CONTAINERLOTION256
65753-602-24CorTex SunX 50 Thick7 g in 1 POUCHLOTION76
65753-602-24CorTex SunX 50 Thick50 in 1 CONTAINERLOTION506
65753-602-26CorTex SunX 50 Thick7 g in 1 POUCHLOTION76
65753-602-26CorTex SunX 50 Thick150 in 1 CARTONLOTION1506
65753-602-31CorTex SunX 50 Thick7 g in 1 POUCHLOTION76
65753-602-31CorTex SunX 50 Thick300 in 1 CARTONLOTION3006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-602CORTEX SUNX 50 THICK (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CORETEX PRODUCTS INC]5Current NDC, 10 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 47 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4a822-a7ab-b374-e063-6394a90a85082026-04-08WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4d44e-3421-535f-e063-6294a90a2fea2026-04-08WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef5baf7-00b1-97aa-e063-6294a90aab9c2026-04-08WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef5dcd4-b2d0-bcd1-e063-6294a90a871f2026-04-08WarningsExact identifier
application number: M020
Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef669b9-df00-8965-e063-6394a90ab3352026-04-08WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef6a60a-6634-e79b-e063-6394a90a3daa2026-04-08WarningsExact identifier
application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef6b5fb-5495-001c-e063-6394a90ab7b32026-04-08WarningsExact identifier
application number: M020
Sunright Lip BalmOCTINOXATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Inc.dfdb2d0a-c646-4c44-b648-e2fdd604cdc92026-04-08WarningsExact identifier
application number: M020
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
application number: M020
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
application number: M020
Vivaiodays SPF 30 Sunscreen with TurmericSPF 30 SUNSCREEN WITH TURMERIC5SENCO INC4ee0c93a-7f50-2bda-e063-6294a90abff42026-04-07WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc4ee39bbf-b7d7-8f87-e063-6294a90a25392026-04-07WarningsExact identifier
application number: M020
BEVERLY HILLS MD SHEER RADIANCE SPF DROPS SUNSCREENZINC OXIDEBeverly Hills MD, LLC4ed34743-cc68-501b-e063-6294a90ad3962026-04-07WarningsExact identifier
application number: M020
Nu Colour Bioadaptive BB plus Foundation - BeigeTITANIUM DIOXIDENSE Products, Inc.f74e83fe-41a0-4998-ae53-30ed5af475922026-04-07WarningsExact identifier
application number: M020
Thinksport SPF 30ZINC OXIDEthinkOperations,LLC33065919-9b4e-4b2b-9306-a706558241c82026-04-07WarningsExact identifier
application number: M020
Nutricentials Day Dream ProtectiveHOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Incdaca8347-f7e7-4733-bd22-1da7a6076fad2026-04-06WarningsExact identifier
application number: M020
TONEfitSUN Ultra Moisturizing Vegan SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory4ec58c23-16b1-03bb-e063-6394a90a46c02026-04-06WarningsExact identifier
application number: M020
Dior Forever Velvet Veil 24H Mattifying Makeup Base Blurring-Smoothing Pore Refining Effect with Sunscreen SPF 15HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Diorbe36b83f-662d-49c6-a12f-a64e11721d0c2026-04-06WarningsExact identifier
application number: M020
Pure SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELiz Corporation Ltd4eca5257-6840-2a33-e063-6394a90ade282026-04-06WarningsExact identifier
application number: M020
Dior Forever Skin Veil 24H Glow Hydrating Base Plumping and Smoothing Effect Hyaluronic Acid with Sunscreen SPF 25ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Dior4a5147f3-4e52-447a-a89c-058aea8a612c2026-04-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65753-602-226575306022225 POUCH in 1 CONTAINER (65753-602-22) / 7 g in 1 POUCH25 pouch2023-03-09NoNoCurrent
65753-602-236575306022325 POUCH in 1 CONTAINER (65753-602-23) / 7 g in 1 POUCH25 pouch2023-03-09NoNoCurrent
65753-602-246575306022450 POUCH in 1 CONTAINER (65753-602-24) / 7 g in 1 POUCH50 pouch2023-03-09NoNoCurrent
65753-602-2665753060226150 POUCH in 1 CARTON (65753-602-26) / 7 g in 1 POUCH150 pouch2023-03-09NoNoCurrent
65753-602-3165753060231300 POUCH in 1 CARTON (65753-602-31) / 7 g in 1 POUCH300 pouch2023-03-09NoNoCurrent