FDA.reportPublic FDA data

Hydrating Sheer Lip Balm Trio The Neutrals

Manufacturer
MDSolarSciences
Effective date
2025-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:53

Label at a glance#

ProductHydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30
Active ingredientOCTISALATE, AVOBENZONE, 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 Reapply: use a water resistant sunscreen if swimming or sweating at least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including: Lim...

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 3%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

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

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
  • Reapply:
    • use a water resistant sunscreen if swimming or sweating
    • at least every 2 hours
  • Children under 6 months: Ask a doctor
  • Sun Protection Measures :Spending time in the sun increases your risk of skin cancer and early skin aging.
    To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection 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, Hydrogenated Soybean Oil, Paraffin, Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Octyldodecanol, Butyloctyl Salicylate, Hydrogenated Vegetable Oil, Jojoba Esters, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Plant-Derived Squalane, Polyglycerin-3, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Ascorbyl Palmitate (Vitamin C), Tocopherol (Vitamin E), Rhus Verniciflua Peel Wax, Acacia Decurrens Flower Wax, Sorbitan Oleate, Synthetic Fluorphlogopite (Dream/Spice), May contain: CI 77891, CI 77491, CI 77492, CI 77499, CI 15850, CI 42090, CI 77861, CI 45410, CI 19140

Company Information

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-002-01Hydrating Sheer Lip Balm Trio The NeutralsBroad Spectrum SPF 301 in 1 CARTONKIT11

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49358-00249358-002-01
49358-003
49358-004
49358-005

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 97 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CI 774911K09F3G675IACT
CI 77492EX438O2MRTIACT
CI 42090H3R47K3TBDIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
SHEA BUTTERK49155WL9YIACT
CI 19140I753WB2F1MIACT
OCTYLDODECANOL461N1O614YIACT
CI 77499XM0M87F357IACT
CI 15850481744AI4OIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
PARAFFINI9O0E3H2ZEIACT
CI 7789115FIX9V2JPIACT
AVOCADO OIL6VNO72PFC1IACT
CASTOR OILD5340Y2I9GIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
STEARIC ACID4ELV7Z65APIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
RHUS VERNICIFLUA PEEL WAX6RG2461FCHIACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OLIVE OIL6UYK2W1W1EIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CI 45410767IP0Y5NHIACT
SQUALANEGW89575KF9IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
TOCOPHEROLR0ZB2556P8IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
HOMOSALATEV06SV4M95SACTIB
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
SORBITAN OLEATE06XEA2VD56IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CI 774911K09F3G675IACT
CI 77492EX438O2MRTIACT
CI 42090H3R47K3TBDIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
SHEA BUTTERK49155WL9YIACT
CI 19140I753WB2F1MIACT
OCTYLDODECANOL461N1O614YIACT

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
Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences374395ea-ab91-de70-e063-6394a90aec562025-06-10WarningsExact identifier
ndc (package): 49358-002-01
ndc (product): 49358-002
ndc11 (package): 49358000201
spl id: 37438c7c-4f6e-ec9d-e063-6394a90aa53b
spl set id: 374395ea-ab91-de70-e063-6394a90aec56

Reported adverse events (FAERS/openFDA)#

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