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 198 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37f01f66-c604-4fc3-a263-2089db91283f2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lbca57893-bd2d-44ac-a503-2f11c3b62bf22025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37188b77-ab0b-4bea-b839-99e589600a2b2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc89e45d6-2322-4913-a557-e1780a86fd632025-08-11WarningsExact identifier
application number: M020
Sun Bum Face 70 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1ed89c-6d50-6400-e063-6294a90a14332025-08-11WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 15mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24e9ea4d-3073-c126-e063-6394a90a7c6e2025-08-10WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM PEACH SHAKEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETId1c5b7a5-73f9-4df6-9469-ce42e4f33ae82025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM VANILLA LATTEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI96efeb92-a276-4ac9-b30a-11b4fa3672632025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER PEACH SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIedeb2ee1-cc84-4254-80c1-6410cd77c4222025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER STRAWBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI7abe936b-a4d5-457c-9cdd-761b201bb0462025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER BLUEBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIe4eb80d8-e75c-4bb7-b3bc-9f05a0f23bab2025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI8be1c27c-7988-47c4-b613-3bc86f53981e2025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM STRAWBERRYAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIa3c8d778-ce9c-46eb-a0c3-6886eb1d39342025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE glow kiss TINTED LIP BALM CHERRY JUICEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI6cdb0b61-a9c2-4a78-9752-8e7aedaeef452025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM BERRY PINKAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIf1b6c068-06d2-4a44-8199-7111d1b6a0d62025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER COOKIE SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI0274f5f1-1ee1-48a5-af7a-deb3aa3a34d72025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER ICE MINT SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIa355777b-2cce-48ce-acc6-2aa7f154c4ba2025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER RASPBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI5443202c-4f88-4063-a227-c50abbd480d62025-08-08WarningsExact identifier
application number: M020
SUNSCREEN SPF50ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDEGuangzhou Tinsun Biotechnology Company Limited3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e2025-08-07WarningsExact 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