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
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 7.5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
AVOBENZONE3 g/100mL
HOMOSALATE7.5 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

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

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