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
4Y5P7MUD51Internal UNII lookup
SOI2LOH54ZInternal 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 271 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tenacious ErgodyneSPF 50 SUNSCREEN LOTIONTenacious Holdings, Inc.aaaa1f54-1136-4062-85ba-0926351580bb2024-10-23WarningsExact identifier
application number: M020
Bull Frog SPF 50 Quik with Water Armor TechAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f706f90c-eb79-2201-e053-6394a90a2ce42024-10-23WarningsExact identifier
application number: M020
Bull Frog SPF 50 Quik with Water Armor TechAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f70816a3-cc04-b000-e053-6294a90a0fae2024-10-23WarningsExact identifier
application number: M020
Alumier MD Post Procedure KitTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs252859de-6676-5e07-e063-6394a90a64a12024-10-23WarningsExact identifier
application number: M020
Equate Sunscreen Tanning Oil With Coconut Oil SPF 6AVOBENZONE, HOMOSALATEWAL-MART STORES INC.f44d83d3-ffca-7a93-e053-2a95a90a77152024-10-23WarningsExact identifier
application number: M020
Tanning Sunscreen UVB Protection Dry Oil EquateAVOBENZONE, HOMOSALATE, OCTISALATEWAL-MART STORES INC.acdf62f2-742e-5df9-e053-2a95a90a96c52024-10-23WarningsExact identifier
application number: M020
WALMART EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWAL-MART STORES INC.c8d4feca-7bee-2413-e053-2a95a90a739c2024-10-23WarningsExact identifier
application number: M020
Equate Sunscreen for All Skin Tones SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWal-Mart Stores Incf410ffcc-ef0e-13c4-e053-2a95a90a568a2024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffbb6af-5a04-f58a-e053-2995a90a1ae22024-10-23WarningsExact identifier
application number: M020
Banana BoatTITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands, LLC441a46f0-ecda-4448-e054-00144ff88e882024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28CHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffb8219-7076-de64-e053-2a95a90a60362024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcfee02eb-92f9-be12-e053-2a95a90a43372024-10-23WarningsExact identifier
application number: M020
CVS Pharmacy Kids SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4eb824a6-66ac-01f8-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health 60 Plus Sensitive Skin SunTITANIUM DIOXIDE, ZINC OXIDECVS Pharmacy477c25ec-33db-04a6-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4eb75945-9d65-55b4-e054-00144ff88e882024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 50 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,CVS Pharmacy4ec6384a-8faf-5712-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 30 ClearAVOBENZONE, HOMOSALATE, OCTOCRYLENE,CVS Pharmacy4ec6b50b-5236-6f5b-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Pharmacy SPF 70 Beach Guard ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4ec75d23-a33b-6c52-e054-00144ff88e882024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 70 Beach Guard SunAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4adbd66a-6b38-046d-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 100 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy651c245c-2d3a-0019-e053-2991aa0a46372024-10-22WarningsExact 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