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
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal 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 18 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc511f6de9-264a-4cf2-97c3-aa8adbc52a872026-06-23WarningsExact identifier
application number: M020
fmg Cashmere Lip Glaze Broad Spectrum SPF 30 SunscreenZINC OXIDETHE AVON COMPANY54f1b153-c79b-bcf8-e063-6394a90ae4262026-06-23WarningsExact identifier
application number: M020
CVS 70 Daily Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY54f25934-b4c4-4fc8-e063-6294a90a543a2026-06-23WarningsExact identifier
application number: M020
Soleil Set sunscreen SPF 50AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%The Soleil Groupcc4e4b99-5f42-4a93-a3a0-ea19f57d27832026-06-23WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY54f6d7c1-59d1-0b36-e063-6394a90a17a32026-06-23WarningsExact identifier
application number: M020
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
application number: M020
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
application number: M020
Mama and Hapa s - Bulk Sunscreen Extra SensitiveZINC OXIDE SUNSCREENVEGANIC SKN LIMITED54e18569-2e51-366a-e063-6394a90af8ec2026-06-22WarningsExact identifier
application number: M020
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
application number: M020
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE COCO LOCOBy the Beach Suncare LLC549be1ca-df21-a643-e063-6394a90ac0262026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL COCO LOCOBy the Beach Suncare LLC549bad35-3005-875b-e063-6394a90ad31e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL MELON DAZEBy the Beach Suncare LLC549bbd19-8e22-e420-e063-6294a90a6a982026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CANDY CLOUDSBy the Beach Suncare LLC549bd1b1-a6e2-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CITRUS CRUSHBy the Beach Suncare LLC549bd1b1-a6ee-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
FHF Elevated Shade 100% Mineral SunscreenSUNSCREENSummer Soles, LLC dba Farm House Freash Goods5488fd8c-7ef2-22c2-e063-6394a90aff3c2026-06-18WarningsExact identifier
application number: M020
Stream2Sea Sport Lip Balm SPF 50ZINC OXIDEStream2Sea, LLC5489fea5-bc0e-82cf-e063-6294a90aa0972026-06-18WarningsExact identifier
application number: M020
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
application number: M020
UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC4a6f9be3-2a56-8b41-e063-6294a90a30f82026-06-18WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50MINERAL SUNSCREENALAINA HEALTHCARE PRIVATE LIMITED7e036f9f-b26d-4f11-911c-c1fa854edb0f2026-06-17WarningsExact 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