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
PETROLATUM; OCTISALATE; OCTINOXATE; AVOBENZONE; HOMOSALATE
Active strength
40; 5; 7.5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
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
Sun X SPF 50 Broad Spectrum Sunscreen Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup
4X49Y0596WInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0355990-b842-47cd-e053-2a95a90a7c82Available 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
65753-108-23Sun 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

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 30 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SP-FFC3-L0TN Barrier Protection Hydrating Mineral Face SunscreenBARRIER PROTECTION HYDRATING MINERAL FACE SUNSCREENEpic Etailers, LLC (DBA: Beauty by Earth)5078479e-a196-7e4d-e063-6394a90ab2662026-05-19WarningsExact identifier
application number: M020
InvisibleMatteBarrierDefenseCeramideSunscreenSerumSPF30SP-FSRM-N0TTINVISIBLE MATTE BARRIER DEFENSE CERAMIDE SUNSCREEN SERUM SPF 30Epic Etailers, LLC (DBA: Beauty by Earth)50790945-f359-07c8-e063-6294a90a5af92026-05-19WarningsExact identifier
application number: M020
Sun Bum Amazon 8 OZ SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum522fc8a4-ce9f-8be8-e063-6294a90aebf02026-05-19WarningsExact identifier
application number: M020
Timesavvy Hybrid Sheer Sun Serum Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEPROBETTER USA INC.66624df4-cb6c-4cfb-bbbe-9f885f2ad7782026-05-18WarningsExact identifier
application number: M020
Hampton Sun SPF 50AVOBENZONE 3.00 % OCTISALATE 5.00 % HOMOSALATE 10.00 %S&C Hampton Sun LLC4df050f9-1185-4ee4-a0cd-84ba9d254e582026-05-18Exact identifier
application number: M020
Hampton Sun SPF 70 KidsAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENES&C Hampton Sun LLC7c976082-3265-4c0b-9985-277d279888952026-05-18WarningsExact identifier
application number: M020
Evereden Kids Cooling Mineral Sunstick SPF30ZINC OXIDEEden Brands Inc.521afa81-737f-81d4-e063-6394a90ad3072026-05-18WarningsExact identifier
application number: M020
cle de peau BEAUTE RESTORATIVE DAY SUPREMEAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporation157e52c5-f6fa-430b-bbb8-86b7c0868ad32026-05-18WarningsExact identifier
application number: M020
cle de peau BEAUTE SKIN BEAUTY ENHANCERAVOBENZONE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporationbc6230f1-dba2-4418-b48c-c5e67aebd1bd2026-05-18WarningsExact identifier
application number: M020
Hampton Sun SPF 30 SILK BODYAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENES&C Hampton Sun LLCed0c184d-473a-4c4c-b6ec-e1d79ad584602026-05-18WarningsExact identifier
application number: M020
Sheer Defense Tinted SPF 46ZINC OXIDE, OCTINOXATEPrivate Label Skin Care017265e9-31e6-43ce-9432-cb88f471c4962026-05-18WarningsExact identifier
application number: M020
Aveeno Daily Moisturizing Face Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC51d59378-df72-e438-e063-6294a90a97f12026-05-15WarningsExact identifier
application number: M020
Natural Sense SPF 50 SunscreenSUNSCREENDr. Natural LLC49a2430e-c15b-4610-e063-6294a90ac5202026-05-15WarningsExact identifier
application number: M020
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc.23cc5ff4-f842-4e3e-ac5c-23dbaf7d39142026-05-15WarningsExact identifier
application number: M020
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDESICOS ET CIEc688f8e6-2cd2-40db-b03f-90fd74c2d89c2026-05-15WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc7df9dbd2-7db9-4961-819d-e93d14a065c32026-05-15WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE20efd5fa-3077-4fd4-82d0-ddca946e45282026-05-15WarningsExact identifier
application number: M020
Target Up and Up Ultra Light Dry-Touch SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51de3d0b-2721-92d3-e063-6394a90a18bb2026-05-15WarningsExact identifier
application number: M020
MELAO Hydrating Lightweight SunscreenOCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd51c353cb-94c4-e110-e063-6394a90a497e2026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 8 Bronze SunscreenHOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%S&C Hampton Sun LLC7cf4d943-be6e-4e38-8891-1e0b22af55362026-05-14WarningsExact 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 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