FDA.reportPublic FDA data

LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 NUDE UNIVERSEL

Product NDC
14141-352
11-digit product format
141410352
Labeler code
14141
Product ID
14141-352_45100706-59a2-05c5-e063-6294a90abf9f
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, ZINC OXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
BEL STAR S A
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-30
Substance
ZINC OXIDE; OCTINOXATE
Active strength
49; 75 mg/g; mg/g
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
LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 NUDE UNIVERSEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE49 mg/g
OCTINOXATE75 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
25b6cb46-6516-376a-e063-6394a90a44f6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-352-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 NUDE UNIVERSEL2 g in 1 TUBESTICK22
14141-352-01LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 NUDE UNIVERSEL1 in 1 BOXSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-352LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 NUDE UNIVERSEL (OCTINOXATE, ZINC OXIDE) STICK LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 CORAL UNIVERSEL (OCTINOXATE, ZINC OXIDE) STICK LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL (OCTINOXATE, ZINC OXIDE) STICK LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 ROSE UNIVERSEL (OCTINOXATE, ZINC OXIDE) STICK [BEL STAR S A]1Current NDC, 2 package rows20241102_25b6cb46-6516-376a-e063-6394a90a44f6.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 143 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b46ac-6dde-72d1-e063-6294a90a03da2025-12-09Exact identifier
application number: M020
ReplenishZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316c43fb-0c15-87d4-e063-6294a90a0a632025-12-09Exact identifier
application number: M020
BIOJUVE Microbiome-Safe Sheer Finish SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesece7565b-f3e5-3386-e053-2a95a90a58022025-12-09WarningsExact identifier
application number: M020
Hydraboost Lip TreatmentAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBluemercury2cf30083-8723-23f6-e063-6394a90a55de2025-12-09WarningsExact identifier
application number: M020
Florida Babe Sport Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31e4756d-8604-6e75-e063-6294a90aebe12025-12-09Exact identifier
application number: M020
Florida Babe Sport Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31e4d9ae-f532-f9f5-e063-6294a90a8d392025-12-09Exact identifier
application number: M020
Arbonne FunSun Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEArbonne International, LLC91bcd120-28e5-4f44-9522-550c1dbcd82c2025-12-09WarningsExact identifier
application number: M020
Florida Babe Active Tinted 20percent Zinc Oxide Mineral SunscreenZINC OXIDETichy Anesthesia PA31e509f2-dcb6-5ae0-e063-6394a90a70c12025-12-09Exact identifier
application number: M020
Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral SunscreenZINC OXIDETichy Anesthesia PA31e57817-b8c4-8178-e063-6294a90a01492025-12-09Exact identifier
application number: M020
Florida Babe Everyday Tinted Replenishing Daily ProtectionZINC OXIDETichy Anesthesia PA3231f1fe-51b3-b2e7-e063-6394a90a27582025-12-09Exact identifier
application number: M020
Florida Babe Everyday Tinted Replenishing Daily ProtectionZINC OXIDETichy Anesthesia PA31e63876-3e39-adc6-e063-6394a90ab1462025-12-09Exact identifier
application number: M020
Florida Babe SPORT Mineral Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31f5bbe4-5f6e-3bef-e063-6294a90a26462025-12-09Exact identifier
application number: M020
Florida Babe SPORT Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31f54a79-70b7-def5-e063-6294a90a709b2025-12-09Exact identifier
application number: M020
Florida Babe Sport Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA3231b71c-4d27-e5e2-e063-6294a90a031b2025-12-09Exact identifier
application number: M020
Arbonne Soft Focus Veil Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEArbonne International, LLC3c9b605b-5a16-4f89-a956-8c4c62de72d32025-12-09WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE AESTHETICS ACADEMY, LLC364b9560-f7a1-ed8f-e063-6294a90a2c412025-12-09Exact identifier
application number: M020
Sunshield Moisturizing Sunscreen and AntioxidantZINC OXIDEOculofacial Surgery andCosmetic Laser Institute, LLC.32c247fc-d4da-e03d-e063-6394a90a72b02025-12-09Exact identifier
application number: M020
SCALP SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEFOLICULE LLC387b10e1-5443-7b7a-e063-6394a90a2c7a2025-12-09Exact identifier
application number: M020
Sunshield Moisturizing Sunscreen and AntioxidantZINC OXIDEOculofacial Surgery andCosmetic Laser Institute, LLC.32c3936e-4089-edd0-e063-6294a90ad3f82025-12-09Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDETHE AESTHETICS ACADEMY, LLC364cf1f7-1f87-51f7-e063-6294a90a789c2025-12-09Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14141-352-01141410352011 TUBE in 1 BOX (14141-352-01) / 2 g in 1 TUBE1 tube2024-10-30NoNoCurrent