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 51 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Natural Ice OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company29220eaa-87cb-4ebe-87db-d36288b3a9e42026-03-24WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLCf54c617f-794e-413b-b898-4a06622b4bee2026-03-24Warnings, Adverse reactionsExact identifier
application number: M020
VITAL PERFECTION UPLIFTING AND FIRMING ADVANCED DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporation7b2d15c1-b9e1-4347-b138-9883f78822b32026-03-24WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd05620-30a3-9cea-e063-6294a90af18b2026-03-24WarningsExact identifier
application number: M020
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd1b722-4448-9675-e063-6294a90a5f4f2026-03-24WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen SPF30NON- NANO ZINC OXIDEDelta Ecommerce LLC2dda185c-6ff8-953d-e063-6394a90acc532026-03-24WarningsExact identifier
application number: M020
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
application number: M020
HALORINNA SUN-SCREEN TRAVEL SPF50SUN SCREENGuangdong Bisutang Biotechnology Co., LTD4dade579-ce77-eea5-e063-6394a90ad46a2026-03-23WarningsExact identifier
application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF30 - 01 HAZY MAUVEZINC OXIDETIRTIR USA Inc.4c92db00-59f1-ac02-e063-6394a90a7cf12026-03-23WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50The Soleil Group, LLC27d20573-0b6b-4d4b-94ca-69b476a883a72026-03-23WarningsExact identifier
application number: M020
Babo Botanicals Hydrating Milk Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.4db37efb-2d37-7428-e063-6394a90a10e42026-03-23WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen ButterZINC OXIDEElemental Herbs, Inc.ff334e9c-dd12-92bc-e053-6394a90aa24b2026-03-23WarningsExact identifier
application number: M020
All Good Tinted Mineral Sunscreen Butter SPF 50ZINC OXIDEElemental Herbs, Inc.fe2bf779-e8b3-933f-e053-6394a90a369f2026-03-23WarningsExact identifier
application number: M020
ULTRA SOOTHER DRY-TOUCH SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEskinnplus4dbc1035-c41c-308c-e063-6394a90a36c42026-03-23WarningsExact identifier
application number: M020
Daily Defense Mineral Sunscreen Serum Broad Spectrum SPF 33ZINC OXIDEEva's Esthetics0dd7cba3-bc74-4ec1-bd4a-a2f3ed533fc72026-03-23WarningsExact identifier
application number: M020
MELAO Rice Probiotics SunscreenZINC OXIDE,ETHYLHEXYL SALICYLATE,ETHYLHEXYL METHOXYCINNAMATEGuangdong Aimu Biological Technology Co., Ltd4ccaa734-83c1-611b-e063-6294a90ab3bf2026-03-21WarningsExact identifier
application number: M020
Vacation Lip Trips Desserts Pineapple Upside Down CakeAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.69022828-8226-4977-a2ca-ad8e16793a592026-03-20WarningsExact identifier
application number: M020
VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.c7794831-52d1-4d80-936d-44af18ae04722026-03-20WarningsExact identifier
application number: M020
YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral SunscreenZINC OXIDECA-Botana International4d74a36c-ff68-afd9-e063-6394a90a08f82026-03-20WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENESICOS ET CIE468d4ed2-e616-aaaf-e063-6294a90af37a2026-03-20WarningsExact 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