FDA.reportPublic FDA data

CoreTex Sun X SPF 30 Multipack New

Product NDC
65753-109
11-digit product format
657530109
Labeler code
65753
Product ID
65753-109_084870bb-b526-c6af-e063-6394a90a1609
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
CoreTex Products
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-08
Substance
OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
5; 3; 7.5; 5 g/100g; g/100g; g/100g; g/100g
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 Sun X SPF 30 Multipack New
Listing expiration
2026-12-31

Active Ingredients#

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

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
f4ed9d7f-2d03-87d1-e053-2a95a90a3b4fAvailable 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
65753-109-22CoreTex Sun X SPF 30 Multipack New25 in 1 CONTAINERLOTION253
65753-109-22CoreTex Sun X SPF 30 Multipack New7 g in 1 POUCHLOTION73
65753-109-23CoreTex Sun X SPF 30 Multipack New25 in 1 CONTAINERLOTION253
65753-109-23CoreTex Sun X SPF 30 Multipack New7 g in 1 POUCHLOTION73
65753-109-24CoreTex Sun X SPF 30 Multipack New7 g in 1 POUCHLOTION73
65753-109-24CoreTex Sun X SPF 30 Multipack New50 in 1 CONTAINERLOTION503
65753-109-26CoreTex Sun X SPF 30 Multipack New300 in 1 BOXLOTION3003
65753-109-26CoreTex Sun X SPF 30 Multipack New7 g in 1 POUCHLOTION73
65753-109-31CoreTex Sun X SPF 30 Multipack New7 g in 1 POUCHLOTION73
65753-109-31CoreTex Sun X SPF 30 Multipack New150 in 1 BOXLOTION1503
65753-109-39CoreTex Professional Outdoor Skin Protection Wallet7 g in 1 POUCHLOTION7 g3 g in 100g3
65753-109-39CoreTex Professional Outdoor Skin Protection Wallet Refill7 g in 1 POUCHLOTION7 g3 g in 100g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-109CORETEX SUN X SPF 30 MULTIPACK NEW (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CORETEX PRODUCTS]3Current NDC, 10 package rows20231022_f4ed9d7f-2d03-87d1-e053-2a95a90a3b4f.zip
65753-109CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET KIT [CORETEX PRODUCTS INC]2Current NDC20241008_f57bc089-405b-cdcd-e053-2995a90a9d12.zip
65753-109CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET REFILL KIT [CORETEX PRODUCTS INC]1Current NDC20231105_095855ef-85f5-dacd-e063-6294a90a597c.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 7 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.22aa46af-5d0f-4256-8f45-be06f66275612026-08-10WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral Body ShieldZINC OXIDEColorescience52e1f59e-63cb-7480-e063-6394a90ad7c52026-08-10WarningsExact identifier
application number: M020
Eucerin Radiant Tone Tinted Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc596a4204-3d29-9023-e063-6294a90ad99e2026-08-10WarningsExact identifier
application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 SunscreenBEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDEGrace and Fire USA Inc.56ad0dce-410e-9d78-e063-6294a90a1c3e2026-08-09WarningsExact identifier
application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex SunscreenETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangzhou Yapheon Health Industry Co., Ltd.552a36ed-7a66-4048-e063-6394a90a09bc2026-08-08WarningsExact identifier
application number: M020
lip balm SPF15( 2533) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5870aa44-1375-cdc5-e063-6394a90af4a52026-08-07WarningsExact identifier
application number: M020
lip balm SPF15( Zinc oxide) 01ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.5871ab1d-cf07-d737-e063-6394a90a58fe2026-08-07WarningsExact identifier
application number: M020
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC58636012-7e29-7206-e063-6394a90a83e92026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864275d-a480-06f8-e063-6394a90aecab2026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864881c-c495-1f32-e063-6294a90a13042026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40ZINC OXIDECP Skin Health Group, Inc945538b5-5745-42cf-b610-0018ca2ec2542026-08-06WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Stream2Sea Ecostock SPF 40 SunscreenZINC OXIDEStream2Sea, LLC5866e026-a652-3300-e063-6394a90acff02026-08-06WarningsExact identifier
application number: M020
NHLMA Skin Defense SunscreenBROAD SPECTRUM SPF 30NATIONAL HAIR LOSS LLC56326ae0-387f-ad08-e063-6294a90acc4f2026-08-06WarningsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC129ae274-0094-be5e-e063-6394a90a98012026-08-05WarningsExact identifier
application number: M020
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact 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
65753-109-226575301092225 POUCH in 1 CONTAINER (65753-109-22) / 7 g in 1 POUCH25 pouch2023-01-08NoNoCurrent
65753-109-236575301092325 POUCH in 1 CONTAINER (65753-109-23) / 7 g in 1 POUCH25 pouch2023-01-08NoNoCurrent
65753-109-246575301092450 POUCH in 1 CONTAINER (65753-109-24) / 7 g in 1 POUCH50 pouch2023-01-08NoNoCurrent
65753-109-2665753010926300 POUCH in 1 BOX (65753-109-26) / 7 g in 1 POUCH300 pouch2023-01-08NoNoCurrent
65753-109-3165753010931150 POUCH in 1 BOX (65753-109-31) / 7 g in 1 POUCH150 pouch2023-01-08NoNoCurrent
65753-109-39657530109397 g in 1 POUCH7 gHistorical