FDA.reportPublic FDA data

CoreTex Professional Outdoor Skin Protection Wallet

Product NDC
65753-514
11-digit product format
657530514
Labeler code
65753
Product ID
65753-514_40c50803-1539-954d-e063-6294a90ab6a7
Type
HUMAN OTC DRUG
Nonproprietary name
CoreTex Professional Outdoor Skin Protection Wallet
Dosage form
KIT
Labeler
CoreTex Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-24
NDC exclude flag
No
Listing certified through
2026-12-31
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
CoreTex Professional Outdoor Skin Protection Wallet
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
582753Internal RxNorm lookup
1043353Internal RxNorm lookup
2263166Internal RxNorm lookup
2263170Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f57bc089-405b-cdcd-e053-2995a90a9d12Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
65753-108-39CoreTex Professional Outdoor Skin Protection Wallet4.44 mL in 1 APPLICATORLIPSTICK65753105 mL7.5 g in 100mL3
65753-109-39CoreTex Professional Outdoor Skin Protection Wallet7 g in 1 POUCHLOTION7 g3 g in 100g3
65753-110-37CoreTex Professional Outdoor Skin Protection Wallet44 mL in 1 PACKETLOTION44 mL7.5 g in 100mL3
65753-400-39CoreTex Professional Outdoor Skin Protection Wallet1 mL in 1 POUCHGEL1 mL2 g in 100mL3
65753-514-35CoreTex Professional Outdoor Skin Protection Wallet1 in 1 KITKIT13
65753-514-36CoreTex Professional Outdoor Skin Protection Wallet1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-514CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET KIT [CORETEX PRODUCTS INC]2Current NDC, 6 package rows20241008_f57bc089-405b-cdcd-e053-2995a90a9d12.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 142 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foam Weightless Sunscreen Non-Tinted Drytouch NTTITANIUM DIOXIDE, ZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC335ec22c-6a9a-c4d1-e063-6394a90ac0b02025-12-09Exact identifier
application number: M020
Mineral Sunscreen Moisturizing Non-TintedZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC3360a208-5f17-a74b-e063-6294a90a13e12025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD323356ea-31a0-6ff0-e063-6294a90a135c2025-12-09Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD32330376-5db0-202b-e063-6294a90add152025-12-09Exact identifier
application number: M020
Sunscreen Plus UntintedZINC OXIDELily Lee, MD32354468-94a2-604b-e063-6394a90adfb52025-12-09Exact identifier
application number: M020
Sunscreen Plus TintedZINC OXIDELily Lee, MD32346536-f542-ef0f-e063-6394a90a04642025-12-09Exact identifier
application number: M020
Sunscreen Plus Mineral Stick UntintedTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD3234b498-5b56-55f4-e063-6294a90a9b872025-12-09Exact identifier
application number: M020
Sunscreen Plus TintedZINC OXIDELily Lee, MD3235a696-92aa-788c-e063-6394a90a01492025-12-09Exact identifier
application number: M020
Sunscreen Plus Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD32351db0-884c-8fa0-e063-6294a90acba22025-12-09Exact identifier
application number: M020
Sunscreen Plus UntintedZINC OXIDELily Lee, MD3235786d-7ba9-c9ab-e063-6294a90a7f2e2025-12-09Exact identifier
application number: M020
Tinted Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC31416d04-2d6f-7cf9-e063-6294a90a98062025-12-09WarningsExact identifier
application number: M020
Matte Invisible Mineral Sunscreen Non-TintedZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3143968a-096e-b9ac-e063-6294a90ada0d2025-12-09WarningsExact identifier
application number: M020
Daily Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC314299b1-a78b-c1bd-e063-6294a90ab43b2025-12-09WarningsExact identifier
application number: M020
Sheer Satin Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3143d8b0-4af8-f52d-e063-6294a90a926b2025-12-09WarningsExact identifier
application number: M020
Matte Invisible Mineral SunscreenZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3142ed0f-f379-f240-e063-6294a90a53032025-12-09WarningsExact identifier
application number: M020
Sheer Non-Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEFace Collection, L.L.C.33d83cfb-045d-141c-e063-6394a90a2e042025-12-09Exact identifier
application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company45875865-5e9c-d652-e063-6394a90ad5fa2025-12-09WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b7584-c782-fe9e-e063-6394a90a76fe2025-12-09Exact identifier
application number: M020
Transparent Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEFace Collection, L.L.C.33dbfd9b-b90f-bb32-e063-6294a90af7dc2025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b46ac-6dde-72d1-e063-6294a90a03da2025-12-09Exact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65753-108-39657530108394.44 mL in 1 APPLICATOR4.44 mlHistorical
65753-109-39657530109397 g in 1 POUCH7 gHistorical
65753-110-376575301103744 mL in 1 PACKET44 mlHistorical
65753-400-39657530400391 mL in 1 POUCH1 mlHistorical
65753-514-35657530514351 KIT in 1 KIT (65753-514-35) * 4.44 mL in 1 APPLICATOR (65753-108-39) * 1.1 mL in 1 POUCH * 1 mL in 1 POUCH (65753-400-39) * 3.5 mL in 1 POUCH * 7 g in 1 POUCH (65753-109-39) * 44 mL in 1 PACKET (65753-110-37) 1 kit2023-02-24NoNoCurrent
65753-514-36657530514361 KIT in 1 KIT (65753-514-36) * 4.44 mL in 1 APPLICATOR (65753-108-39) * 1.1 mL in 1 POUCH * 1 mL in 1 POUCH (65753-400-39) * 3.5 mL in 1 POUCH * 7 g in 1 POUCH (65753-109-39) * 44 mL in 1 PACKET (65753-110-37) 1 kit2023-02-24NoNoCurrent