FDA.reportPublic FDA data

CoreTex Sun X SPF 30 New

Product NDC
65753-110
11-digit product format
657530110
Labeler code
65753
Product ID
65753-110_08fb1bbf-f361-29da-e063-6394a90aa397
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
2021-01-07
Substance
OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
5; 3; 7.5; 5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65753-11065753-110-40DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
CoreTex Sun X SPF 30 New
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE5 g/100mL
AVOBENZONE3 g/100mL
HOMOSALATE7.5 g/100mL
OCTISALATE5 g/100mL

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
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08fb4748-d22d-35af-e063-6394a90a0827Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-110-37CoreTex Professional Outdoor Skin Protection Wallet44 mL in 1 PACKETLOTION44 mL7.5 g in 100mL3
65753-110-01CoreTex Sun X SPF 30 New30 mL in 1 BOTTLE, PLASTICLOTION301
65753-110-02CoreTex Sun X SPF 30 New59 mL in 1 BOTTLE, PLASTICLOTION591
65753-110-03CoreTex Sun X SPF 30 New118 mL in 1 BOTTLE, PLASTICLOTION1181
65753-110-04CoreTex Sun X SPF 30 New177 mL in 1 BOTTLE, PLASTICLOTION1771
65753-110-05CoreTex Sun X SPF 30 New236 mL in 1 BOTTLE, PLASTICLOTION2361
65753-110-07CoreTex Sun X SPF 30 New473 mL in 1 BOTTLE, PLASTICLOTION4731
65753-110-08CoreTex Sun X SPF 30 New500 mL in 1 BAGLOTION5001
65753-110-08CoreTex Sun X SPF 30 New1 in 1 BOXLOTION11
65753-110-09CoreTex Sun X SPF 30 New946 mL in 1 BOTTLE, PLASTICLOTION9461
65753-110-10CoreTex Sun X SPF 30 New3785 mL in 1 BOTTLE, PLASTICLOTION37851
65753-110-18CoreTex Sun X SPF 30 New1000 in 1 CARTONLOTION10001
65753-110-18CoreTex Sun X SPF 30 New44 mL in 1 PACKETLOTION441
65753-110-22CoreTex Sun X SPF 30 New7 mL in 1 PACKETLOTION71
65753-110-22CoreTex Sun X SPF 30 New25 in 1 CONTAINERLOTION251
65753-110-23CoreTex Sun X SPF 30 New7 mL in 1 PACKETLOTION71
65753-110-23CoreTex Sun X SPF 30 New50 in 1 CONTAINERLOTION501
65753-110-24CoreTex Sun X SPF 30 New50 in 1 CARTONLOTION501
65753-110-24CoreTex Sun X SPF 30 New7 mL in 1 PACKETLOTION71
65753-110-25CoreTex Sun X SPF 30 New7 mL in 1 PACKETLOTION71
65753-110-25CoreTex Sun X SPF 30 New100 in 1 CARTONLOTION1001
65753-110-26CoreTex Sun X SPF 30 New7 mL in 1 PACKETLOTION71
65753-110-26CoreTex Sun X SPF 30 New300 in 1 BOXLOTION3001
65753-110-32CoreTex Sun X SPF 30 New44 mL in 1 BOTTLE, PLASTICLOTION441
65753-110-33CoreTex Sun X SPF 30 New59 mL in 1 BOTTLE, PLASTICLOTION591
65753-110-34CoreTex Sun X SPF 30 New118 mL in 1 BOTTLE, PLASTICLOTION1181
65753-110-35CoreTex Sun X SPF 30 New751 mL in 1 BOTTLELOTION7511
65753-110-37CoreTex Professional Outdoor Skin Protection Wallet Refill44 mL in 1 PACKETLOTION44 mL7.5 g in 100mL1
65753-110-37CoreTex Sun X SPF 30 New44 mL in 1 PACKETLOTION441
65753-110-40CoreTex Sun X SPF 30 New1 in 1 BOXLOTION11
65753-110-40CoreTex Sun X SPF 30 New751 mL in 1 BOTTLELOTION7511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-110CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET KIT [CORETEX PRODUCTS INC]2Current NDC20241008_f57bc089-405b-cdcd-e053-2995a90a9d12.zip
65753-110CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET REFILL KIT [CORETEX PRODUCTS INC]1Current NDC20231210_0a9523f7-d008-b05f-e063-6394a90a615d.zip
65753-110CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET REFILL KIT [CORETEX PRODUCTS INC]1Current NDC20231105_095855ef-85f5-dacd-e063-6294a90a597c.zip
65753-110CORETEX SUN X SPF 30 NEW (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CORETEX PRODUCTS INC]1Current NDC, 29 package rows20231031_08fb4748-d22d-35af-e063-6394a90a0827.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 116 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c043e0-fd6c-5f7a-e063-6294a90a88992025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0c1ca-80a8-9d37-e063-6294a90a824f2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0f5df-6bfb-3c0d-e063-6294a90a2e5f2025-12-16Exact identifier
application number: M020
Daily Protect Mineral SunscreenZINC OXIDESARAH'S4617beb7-381e-8994-e063-6394a90a14b52025-12-16WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENTENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDEShiseido Americas Corporation8db9f5e0-a8d6-4872-b4c6-cb92c43d25c22025-12-16WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation18ed9b7f-bdbe-45d7-a38c-6d065080ae992025-12-16WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE FOR BODY NENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationa2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c2025-12-16WarningsExact identifier
application number: M020
b.tan Beach Please SPF 7AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarque of Brands Americas, LLCbdc07d83-a34f-5262-e053-2995a90acfc32025-12-16WarningsExact identifier
application number: M020
Daily Protect Tinted Mineral SunscreenZINC OXIDESARAH'S461910bd-1f74-f99e-e063-6394a90ae30e2025-12-16WarningsExact identifier
application number: M020
Daily Protect Tinted Mineral SunscreenZINC OXIDESARAH'S4619b08f-3e63-25aa-e063-6294a90a78d72025-12-16WarningsExact identifier
application number: M020
megALL DAY SOOTHE SUN SHIELD BROAD SPECTRUM SPF48Meg Cosmetics Inc4526bacf-6451-b297-e063-6294a90af71a2025-12-16WarningsExact identifier
application number: M020
Total Eye 3-In-1 Renewal Therapy SPF 35TITANIUM DIOXIDE AND ZINC OXIDEColorescience4b116cc4-94d2-4bfc-b7f9-5f486a194c6c2025-12-16WarningsExact identifier
application number: M020
Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32ZINC OXIDEOnekind.25c11197f4-cee0-04b3-e053-2995a90a1ba82025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Medium DeepZINC OXIDECrunchi, LLC.69618265-2ebb-4cdc-a28f-e36c07fe5b8f2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 MediumZINC OXIDECrunchi, LLC.23248bc3-1b82-443a-b38a-df7f0efb5d2a2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 LightZINC OXIDECrunchi, LLC.cf4039f5-00ee-4227-a3dc-61995c8001352025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Body Sunscreen SPF 30ZINC OXIDECrunchi, LLC.227f5a41-8c3c-492d-947f-e2b046208bca2025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Light MediumZINC OXIDECrunchi, LLC.5b3f2766-065b-4817-a5ff-bd1c7882bfc92025-12-15WarningsExact identifier
application number: M020
Crunchi Sunlight Daily Facial Sunscreen SPF 30ZINC OXIDECruchi, LLC.4f3bcfa0-e43e-4284-afaa-6488ddd749f02025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543a22c-34d5-e572-e063-6394a90ad5792025-12-15Exact identifier
application number: M020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043353benzocaine 6 % Medicated PadPSNf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.1 % / diphenhydrAMINE HCl 2 % / zinc acetate 1 % Topical GelPSNf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethanol 70 % Topical SolutionPSNf57bc089-405b-cdcd-e053-2995a90a9d123
2263166StingX 6 % Topical SwabPSNf57bc089-405b-cdcd-e053-2995a90a9d123
2263166benzocaine 60 MG/ML Medicated Pad [StingX]SBDf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 60 MG/ML Medicated PadSCDf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.001 MG/MG / diphenhydramine hydrochloride 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSCDf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethanol 0.7 ML/ML Topical SolutionSCDf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 6 % Medicated WipeSYf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 6 % Topical SwabSYf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.001 MG/MG / diphenhydramine HCl 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSYf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.1 % / diphenhydramine HCl 2 % / zinc acetate 1 % Topical GelSYf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethanol 70 % Topical SolutionSYf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethyl alcohol 70 % Topical SolutionSYf57bc089-405b-cdcd-e053-2995a90a9d123
2263166StingX 60 MG/ML Medicated PadSYf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 6 % Medicated PadPSN095855ef-85f5-dacd-e063-6294a90a597c1
2263170camphor 0.1 % / diphenhydrAMINE HCl 2 % / zinc acetate 1 % Topical GelPSN095855ef-85f5-dacd-e063-6294a90a597c1
1039474ethanol 62.5 % Topical SolutionPSN095855ef-85f5-dacd-e063-6294a90a597c1
2263166StingX 6 % Topical SwabPSN095855ef-85f5-dacd-e063-6294a90a597c1
2263166benzocaine 60 MG/ML Medicated Pad [StingX]SBD095855ef-85f5-dacd-e063-6294a90a597c1
1043353benzocaine 60 MG/ML Medicated PadSCD095855ef-85f5-dacd-e063-6294a90a597c1
2263170camphor 0.001 MG/MG / diphenhydramine hydrochloride 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSCD095855ef-85f5-dacd-e063-6294a90a597c1
1039474ethanol 0.625 ML/ML Topical SolutionSCD095855ef-85f5-dacd-e063-6294a90a597c1
1043353benzocaine 6 % Medicated WipeSY095855ef-85f5-dacd-e063-6294a90a597c1
1043353benzocaine 6 % Topical SwabSY095855ef-85f5-dacd-e063-6294a90a597c1
2263170camphor 0.001 MG/MG / diphenhydramine HCl 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSY095855ef-85f5-dacd-e063-6294a90a597c1
2263170camphor 0.1 % / diphenhydramine HCl 2 % / zinc acetate 1 % Topical GelSY095855ef-85f5-dacd-e063-6294a90a597c1
1039474ethanol 62.5 % Topical SolutionSY095855ef-85f5-dacd-e063-6294a90a597c1
2263166StingX 60 MG/ML Medicated PadSY095855ef-85f5-dacd-e063-6294a90a597c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65753-110-016575301100130 mL in 1 BOTTLE, PLASTIC (65753-110-01) 30 ml2021-01-07NoNoCurrent
65753-110-026575301100259 mL in 1 BOTTLE, PLASTIC (65753-110-02) 59 ml2021-01-07NoNoCurrent
65753-110-0365753011003118 mL in 1 BOTTLE, PLASTIC (65753-110-03) 118 ml2021-01-07NoNoCurrent
65753-110-0465753011004177 mL in 1 BOTTLE, PLASTIC (65753-110-04) 177 ml2021-01-07NoNoCurrent
65753-110-0565753011005236 mL in 1 BOTTLE, PLASTIC (65753-110-05) 236 ml2021-01-07NoNoCurrent
65753-110-0765753011007473 mL in 1 BOTTLE, PLASTIC (65753-110-07) 473 ml2021-01-07NoNoCurrent
65753-110-08657530110081 BAG in 1 BOX (65753-110-08) / 500 mL in 1 BAG1 bag2021-01-07NoNoCurrent
65753-110-0965753011009946 mL in 1 BOTTLE, PLASTIC (65753-110-09) 946 ml2021-01-07NoNoCurrent
65753-110-10657530110103785 mL in 1 BOTTLE, PLASTIC (65753-110-10) 3785 ml2021-01-07NoNoCurrent
65753-110-18657530110181000 PACKET in 1 CARTON (65753-110-18) / 44 mL in 1 PACKET1000 packet2021-01-07NoNoCurrent
65753-110-226575301102225 PACKET in 1 CONTAINER (65753-110-22) / 7 mL in 1 PACKET25 packet2021-01-07NoNoCurrent
65753-110-236575301102350 PACKET in 1 CONTAINER (65753-110-23) / 7 mL in 1 PACKET50 packet2021-01-07NoNoCurrent
65753-110-246575301102450 PACKET in 1 CARTON (65753-110-24) / 7 mL in 1 PACKET50 packet2021-01-07NoNoCurrent
65753-110-2565753011025100 PACKET in 1 CARTON (65753-110-25) / 7 mL in 1 PACKET100 packet2021-01-07NoNoCurrent
65753-110-2665753011026300 PACKET in 1 BOX (65753-110-26) / 7 mL in 1 PACKET300 packet2021-01-07NoNoCurrent
65753-110-326575301103244 mL in 1 BOTTLE, PLASTIC (65753-110-32) 44 ml2021-01-07NoNoCurrent
65753-110-336575301103359 mL in 1 BOTTLE, PLASTIC (65753-110-33) 59 ml2021-01-07NoNoCurrent
65753-110-3465753011034118 mL in 1 BOTTLE, PLASTIC (65753-110-34) 118 ml2021-01-07NoNoCurrent
65753-110-3565753011035751 mL in 1 BOTTLE (65753-110-35) 751 ml2022-01-07NoNoCurrent
65753-110-376575301103744 mL in 1 PACKET (65753-110-37) 44 ml2021-01-07NoNoCurrent
65753-110-40657530110401 in 1 BOXHistorical