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
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal 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 102 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CreamZINC OXIDEMONAT GLOBAL CORPe9231470-9292-0e70-e053-2a95a90a767a2025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe92288bb-739a-2f73-e053-2995a90ac01f2025-12-26WarningsExact identifier
application number: M020
StriVectin-SH NIA-114 UVA UVB Shields SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONEStriVectin Operating Company Inc.232cbde4-d8ea-4831-9b44-c2e93203260a2025-12-26WarningsExact identifier
application number: M020
CardonAVOBENZONE, HOMOSALATE, OCTYL SALICYLATECardon, Inc72ee2c06-242e-29a2-e053-2991aa0ad8dc2025-12-26WarningsExact identifier
application number: M020
OUHOE Water-Permeable SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46e63e1e-7851-ca26-e063-6394a90a9b532025-12-26WarningsExact identifier
application number: M020
OUHOE Sun MilkTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46e678dd-13c5-b317-e063-6294a90aa9892025-12-26WarningsExact identifier
application number: M020
Dermatone Sport SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Dermatone Labs LLC0e60e5bb-b941-4114-933a-29480bff59602025-12-24WarningsExact identifier
application number: M020
Intelligent Elixirs Tinted Broad Spectrum SPF 30 - NaturalAVOBENZONE, OCTISALATE, OCTINOXATEIntelligent Elixirs, LLC287a61d8-0056-6211-e063-6394a90aa3da2025-12-24WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen for the faceHOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b5997-d229-60ee-e063-6394a90a68db2025-12-23WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Solar Shimmer Sunscreen for the faceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bcab9-9b75-a17c-e063-6294a90aafd92025-12-23WarningsExact identifier
application number: M020
DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAYAVOBENZONE, OCTINOXATE, OCTISALATEKOS America, Inc.81352963-36ec-4099-af51-3498d89f30772025-12-23WarningsExact identifier
application number: M020
Poolside Soft Serve Mineral Milk SPF 30 face sunscreen dropsZINC OXIDE, OCTINOXATELongway Technology(Guangzhou)Co.,Ltd.451b4d37-99e2-8e4f-e063-6294a90a51bb2025-12-23WarningsExact identifier
application number: M020
Reclaim Revolutionary Anti-Aging Day SPF15OCTINOXATE, OCTISALATE, AND OXYBENZONEGuthy-Renker LLC4b735c91-f650-4531-8744-c211d57a3e282025-12-23WarningsExact identifier
application number: M020
SCINIC ENJOY SUPER MILD SUN ESSENCE EXAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEELEVEN STREET35272744-8253-046c-e063-6394a90aabc22025-12-22WarningsExact identifier
application number: M020
TINTED FACIAL SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1259035e-9196-97de-e063-6394a90a9dec2025-12-22WarningsExact identifier
application number: M020
SUNSCREEN LIP BALMETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, POLYSILICONE-15, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Tata Biotechnology Co., Ltd.0f8e08bf-4b14-bdad-e063-6394a90a34e12025-12-22WarningsExact identifier
application number: M020
SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENEGuangzhou Tata Biotechnology Co., Ltd.1c32b019-a038-eb61-e063-6394a90a45f22025-12-22WarningsExact identifier
application number: M020
SPF 50 MINERAL SUNSCREEN LIPZINC OXIDE , TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1c6f0964-9bee-1c06-e063-6294a90ac2a42025-12-22WarningsExact identifier
application number: M020
Absolut Skin SPF 50 Moisturizing SunscreenETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL SALICYLATE,METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL,OCTOCRYLENEGuangzhou Tata Biotechnology Co., Ltd.3264543c-e8f5-da9a-e063-6394a90ac8c62025-12-22WarningsExact identifier
application number: M020
Firmarine Moisturizer SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATEErno Laszlo, Inc.073f8b95-6f46-4341-817f-22f5b4f325422025-12-22WarningsExact 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