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 101 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mine Line Coconut Sunscreen SPF 50ZINC OXIDESpa de Soleil4642b1cc-43b1-6997-e063-6394a90ac7642025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 30 Broad Spectrum SunscreenSPF 30 BROAD SPECTRUM SUNSCREENSnugZ/USA, LLC69ac1218-76e6-04ff-e053-2a91aa0a40802025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Sunscreen SprySPF 50 SUNSCREEN SPRAYSnugZ USA9390ea21-9f9f-14e2-e053-2a95a90ac5772025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 15 Flavored Beeswax Lip BalmSPF 15 FLAVORED BEESWAX LIP BALMSnugZ/USA, LLC69bdfaaf-d49e-bf31-e053-2a91aa0affd32025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Broad Spectrum SunscreenSPF 50 BROAD SPECTRUM SUNSCREENSnugZ/USA, LLCb7a3eed5-c8ca-ffda-e053-2a95a90a73bb2025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 15 Beeswax Lip BalmSPF 15 BEESWAX LIP BALMSnugZ/USA, LLC68816d3a-dbe9-7ce3-e053-2a91aa0a395e2025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 30 Soy Lip BalmSPF 30 SOY LIP BALMSnugZ/USA, LLC687ff49d-2d0e-2534-e053-2991aa0a28642025-12-29WarningsExact identifier
application number: M020
SnugZ SPF 50 Sunscreen StickSPF 50 SUNSTICKSnugZ/USA, LLC6e1179cf-5bfb-1156-e053-2991aa0a5b462025-12-29WarningsExact identifier
application number: M020
OUHOE Face Body SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d36f60-2a5d-816e-e063-6294a90a2ddc2025-12-26WarningsExact identifier
application number: M020
OUHOE Bean SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46d3b11f-93d9-0e38-e063-6294a90a41c32025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe922d89c-4232-77d8-e053-2995a90a85e52025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe9231470-9292-0e70-e053-2a95a90a767a2025-12-26WarningsExact identifier
application number: M020
CreamZINC OXIDEMONAT GLOBAL CORPe92288bb-739a-2f73-e053-2995a90ac01f2025-12-26WarningsExact identifier
application number: M020
StriVectin-SH NIA-114 UVA UVB Shields SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONEStriVectin Operating Company Inc.232cbde4-d8ea-4831-9b44-c2e93203260a2025-12-26WarningsExact identifier
application number: M020
CardonAVOBENZONE, HOMOSALATE, OCTYL SALICYLATECardon, Inc72ee2c06-242e-29a2-e053-2991aa0ad8dc2025-12-26WarningsExact identifier
application number: M020
OUHOE Water-Permeable SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46e63e1e-7851-ca26-e063-6394a90a9b532025-12-26WarningsExact identifier
application number: M020
OUHOE Sun MilkTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.46e678dd-13c5-b317-e063-6294a90aa9892025-12-26WarningsExact identifier
application number: M020
Dermatone Sport SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%Dermatone Labs LLC0e60e5bb-b941-4114-933a-29480bff59602025-12-24WarningsExact identifier
application number: M020
Intelligent Elixirs Tinted Broad Spectrum SPF 30 - NaturalAVOBENZONE, OCTISALATE, OCTINOXATEIntelligent Elixirs, LLC287a61d8-0056-6211-e063-6394a90aa3da2025-12-24WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen for the faceHOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b5997-d229-60ee-e063-6394a90a68db2025-12-23WarningsExact 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