FDA.reportPublic FDA data

Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm

Product NDC
65753-108
11-digit product format
657530108
Labeler code
65753
Product ID
65753-108_0a949f6f-d5f5-8eb2-e063-6394a90aa6a5
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
CoreTex Products, INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-01
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; PETROLATUM
Active strength
3; 3; 7.5; 5; 40 g/100mL; 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
Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE3 g/100mL
OCTINOXATE7.5 g/100mL
OCTISALATE5 g/100mL
PETROLATUM40 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W, 4T6H12BN9U

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
65753-108-23Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm4.44 mL in 1 APPLICATORLIPSTICK4.446
65753-108-23Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm50 in 1 CONTAINERLIPSTICK506
65753-108-36Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm24 in 1 CONTAINERLIPSTICK246
65753-108-36Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm4.44 mL in 1 APPLICATORLIPSTICK4.446
65753-108-38Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm4.44 mL in 1 APPLICATORLIPSTICK4.446
65753-108-38Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm72 in 1 CONTAINERLIPSTICK726
65753-108-39CoreTex Professional Outdoor Skin Protection Wallet4.44 mL in 1 APPLICATORLIPSTICK65753105 mL7.5 g in 100mL3
65753-108-39CoreTex Professional Outdoor Skin Protection Wallet Refill4.44 mL in 1 APPLICATORLIPSTICK65753105 mL40 g in 100mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-108SUN X SPF 50 BROAD SPECTRUM SUNSCREEN LIP BALM (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUM) LIPSTICK [CORETEX PRODUCTS, INC]6Current NDC, Legacy NDC, 6 package rows20231210_c0355990-b842-47cd-e053-2a95a90a7c82.zip
65753-108CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET KIT [CORETEX PRODUCTS INC]2Current NDC, Legacy NDC20241008_f57bc089-405b-cdcd-e053-2995a90a9d12.zip
65753-108CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET REFILL KIT [CORETEX PRODUCTS INC]1Current NDC, Legacy NDC20231105_095855ef-85f5-dacd-e063-6294a90a597c.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 startMarketing endSampleExclude flagStatus
65753-108-236575301082350 APPLICATOR in 1 CONTAINER (65753-108-23) / 4.44 mL in 1 APPLICATOR50 applicator2021-10-080000-00-00NoNoCurrent
65753-108-366575301083624 APPLICATOR in 1 CONTAINER (65753-108-36) / 4.44 mL in 1 APPLICATOR24 applicator2021-10-080000-00-00NoNoCurrent
65753-108-386575301083872 APPLICATOR in 1 CONTAINER (65753-108-38) / 4.44 mL in 1 APPLICATOR72 applicator2021-10-080000-00-00NoNoCurrent
65753-108-39657530108394.44 mL in 1 APPLICATOR4.44 mlHistorical