Hydrating Sheer Lip Balm SPF 30 - TRIO

Manufacturer
MDSolarSciences
Effective date
2019-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:38

Label at a glance#

ProductHydrating Sheer Lip Balm SPF 30 - TRIO
Active ingredientAvobenzone, Octisalate, Homosalate
Label structure9 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure & again after swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor Sun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective measures including: Limit time in the sun, especially from 10a.m.-2p.m. Wear long-sleeved shirts, pants, hats ...

Storage and handling

Protect the product in this container from excessive heat and direct sunlight You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Avobenzone 2%Sunscreen
Octisalate 5%Sunscreen
Homosalate 10%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure & again after swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor
  • Sun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective measures including:
  • Limit time in the sun, especially from 10a.m.-2p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sunlight
  • You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Paraffin Wax, Hydrogenated Soybean Oil, Ricinus Communis (Castor) Seed Oil, Octyldodecanol, Olea Europaea (Olive) Fruit Oil, Jojoba Esters, Hydrogenated Vegetable Oil, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Squalane, Acacia Decurrens Flower Wax, Polyglycerin-3, Rhus Verniciflua Peel Wax, Sorbitan Oleate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491- Red), Iron Oxides (CI 77492 - Yellow), Iron Oxides (CI 77499 - Black) CI 19140 - Yellow 5, Red 28 Lake (CI 45410)

SPL UNCLASSIFIED SECTION

Distributed by: MDSolarSciences Corp, Stamford, CT 06902

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MDSolarSciences™

30
HYDRATING
SHEER
LIP BALM
TRIO

BROAD SP ECTRUM SPF 30 UVA- UVB SUNSCRE EN

Net Wt. 4.2 g -.15Oz

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49358-567-012023-01-30C16284748780-1f386c649-b6da-0266-e053-dadaa90a7c1aHydrating Sheer Lip Balm SPF 30 - TRIO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-564-01Hydrating Sheer Lip Balm SPF 30 - TRIO4.2 g in 1 APPLICATORLIPSTICK4.2 g100 mg in 1g1
49358-565-01Hydrating Sheer Lip Balm SPF 30 - TRIO4.2 g in 1 APPLICATORLIPSTICK4.2 g50 mg in 1g1
49358-566-01Hydrating Sheer Lip Balm SPF 30 - TRIO4.2 g in 1 APPLICATORLIPSTICK4.2 g50 mg in 1g1
49358-567-01Hydrating Sheer Lip Balm SPF 30 - TRIO1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-564HYDRATING SHEER LIP BALM SPF 30 - TRIO (AVOBENZONE, OCTISALATE, AND HOMOSALATE) KIT [MDSOLARSCIENCES]1Legacy NDC20191001_8665d33d-0fe7-42da-b33c-0bedb3e7efd8.zip
49358-565HYDRATING SHEER LIP BALM SPF 30 - TRIO (AVOBENZONE, OCTISALATE, AND HOMOSALATE) KIT [MDSOLARSCIENCES]1Legacy NDC20191001_8665d33d-0fe7-42da-b33c-0bedb3e7efd8.zip
49358-566HYDRATING SHEER LIP BALM SPF 30 - TRIO (AVOBENZONE, OCTISALATE, AND HOMOSALATE) KIT [MDSOLARSCIENCES]1Legacy NDC20191001_8665d33d-0fe7-42da-b33c-0bedb3e7efd8.zip
49358-567HYDRATING SHEER LIP BALM SPF 30 - TRIO (AVOBENZONE, OCTISALATE, AND HOMOSALATE) KIT [MDSOLARSCIENCES]1Legacy NDC, 4 package rows20191001_8665d33d-0fe7-42da-b33c-0bedb3e7efd8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 90 matching rows.

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e070dd54-e126-47b3-ba67-975b9dc751108665d33d-0fe7-42da-b33c-0bedb3e7efd82019-08-06WarningsExact identifier
spl id: e070dd54-e126-47b3-ba67-975b9dc75110
spl set id: 8665d33d-0fe7-42da-b33c-0bedb3e7efd8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.