Hydrating Sheer Lip Balm Trio The Neutrals

Hydrating Sheer Lip Balm Trio The Neutrals
SPL v1
SPL
SPL Set ID 374395ea-ab91-de70-e063-6394a90aec56
Route
TOPICAL
Published
Effective Date 2023-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Avobenzone (30 mg) Homosalate (100 mg)
Inactive Ingredients
Alpha-tocopherol Acetate Ci 77491 Ci 77492 Ci 42090 Jojoba Oil, Randomized Shea Butter Ci 19140 Octyldodecanol Ci 77499 Ci 15850 Tetrahexyldecyl Ascorbate Paraffin Ci 77891 Avocado Oil Castor Oil Microcrystalline Wax Stearic Acid Helianthus Annuus (sunflower) Seed Wax Rhus Verniciflua Peel Wax Olive Oil Ascorbyl Palmitate Ci 45410 Squalane Polyglycerin-3 Tocopherol Butyloctyl Salicylate Hydrogenated Soybean Oil Acacia Decurrens Flower Wax Sorbitan Oleate Magnesium Potassium Aluminosilicate Fluoride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-10
Description

Drug Facts

Medication Information

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50570-1
  • Do not use on damaged or broken skin
Section 55105-1
Active ingredients Purpose
Avobenzone 3% Sunscreen
Octisalate 5% Sunscreen
Homosalate 10% Sunscreen
Warnings

For external use only

Directions
  • 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
  • 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
Company Information

DISTRIBUTED BY

MDSOLARSCIENCES CORP.

GREENS FARMS, CT 06838

Inactive Ingredients

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

Principal Display Panel

Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
Section 55105-1 (55105-1)
Active ingredients Purpose
Avobenzone 3% Sunscreen
Octisalate 5% Sunscreen
Homosalate 10% Sunscreen
Warnings

For external use only

Directions
  • 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
  • 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
Company Information

DISTRIBUTED BY

MDSOLARSCIENCES CORP.

GREENS FARMS, CT 06838

Inactive Ingredients

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.873557 · Updated: 2026-03-14T23:08:59.288880