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 145 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEASHLEY SAMAI38f457fa-0e95-7298-e063-6394a90adda82025-12-09Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEOLGA KLIMOV INC387b41a4-057f-88af-e063-6394a90adbbe2025-12-09Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEOLGA KLIMOV INC387b8ae6-c48b-905c-e063-6394a90a31fb2025-12-09Exact identifier
application number: M020
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS36ea709b-3536-5052-e063-6394a90a48f92025-12-09Exact identifier
application number: M020
Age Defying Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b028159-f240-2cf2-e063-6294a90a32b52025-12-09WarningsExact identifier
application number: M020
Ultimate Mineral ProtectionZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b02bf69-b648-56e1-e063-6294a90aeef32025-12-09WarningsExact identifier
application number: M020
G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.01dcfd14-7a1d-98fa-e063-6294a90a03362025-12-09WarningsExact identifier
application number: M020
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS3aff2074-1514-b5c5-e063-6394a90a75722025-12-09Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER3729d270-64ac-4d2e-e063-6294a90aeb2c2025-12-09Exact identifier
application number: M020
Non Tinted Replenishing Daily ProtectionZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER372a41f6-40f6-4971-e063-6394a90a83e02025-12-09Exact identifier
application number: M020
Stay Shady Non-Tinted Mineral SunscreenZINC OXIDEAMOIE ALAYVILLA3b277237-3a2e-1fb0-e063-6294a90adf202025-12-09WarningsExact identifier
application number: M020
Stay Shady Non-Tinted Mineral SunscreenZINC OXIDEAMOIE ALAYVILLA3b27225f-4589-d915-e063-6294a90a72252025-12-09WarningsExact identifier
application number: M020
Replenishing Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC3738a0c3-5c07-e49b-e063-6394a90a38e92025-12-09Exact identifier
application number: M020
Replenishing Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC37385fc6-1cde-8aa6-e063-6294a90a60172025-12-09Exact identifier
application number: M020
Replenishing Tinted SunscreenZINC OXIDEBeauty Journey Studio LLC3738e5e0-f6d9-0568-e063-6294a90a67b62025-12-09Exact identifier
application number: M020
JAYSUING Matte Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456b44da-02f3-93a0-e063-6294a90a8d062025-12-08WarningsExact identifier
application number: M020
JAYSUING Matte Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456c2974-d499-7841-e063-6294a90a98eb2025-12-08WarningsExact identifier
application number: M020
JAYSUING Ginseng Moist Sun SerumTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456cfa70-f524-f5cb-e063-6394a90ae7dc2025-12-08WarningsExact identifier
application number: M020
Face and Body SunscreenNON-NANO ZINC OXIDE 25%Guangzhou Shengyanghui Industrial Trading Co., Ltd3ee96538-06e8-75b1-e063-6394a90a52852025-12-08WarningsExact identifier
application number: M020
Safe Sea SPF sport 65HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD0ed3242b-ac35-4d98-a777-1e44bb32a4672025-12-08WarningsExact 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