Super Lysine Plus Tangerine Lip Treatment Lipstick
FDA Label NDC 70084-230

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quantum, Inc. for the product Super Lysine Plus Tangerine Lip Treatment (NDC 70084-230). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY: QUANTUM, INC. PO BOX 2791, EUGENE, OR 97402

Otc - Purpose

Active IngredientsPurpose
Octinoxate 7.0%Sunscreen
Oxybenzone (Benzophenone-3) 5.0%Sunscreen

Uses

Helps protect against sunburn and chapped lips.

Warnings

  • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
  • For external use only.

Otc - Do Not Use

  • Do not use on damaged or broken skin.

Otc - Stop Use

  • Stop use and consult a doctor if rash occurs.
  • Avoid contact with eyes. If in eyes, rinse with warm water to remove.

Otc - Keep Out Of Reach Of Children

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

Directions

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Beeswax, Calendula Officinalis Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cholecalciferol (Vitamin D), Copernicia Cerifera (Carnauba) Wax, Echinacea Purpurea Extract, Gum Benzoin Tincture, Hydrastis Canadensis (Goldenseal) Leaf, Lysine, Melaleuca Alternifolia (Tea Tree) Oil, Melaleuca Cajuputi (Cajeput) Oil, Natural Flavor, Propolis Extract, Purified Water, Retinyl Palmitate (Vitamin A), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Tocopheryl Acetate (Vitamin E).

Principal Display Panel - 5 G Cylinder Label

Quantum®
HEALTH

PEEL LABEL
FOR DRUG FACTS

SuperLysine+®

Tangerine Flavor
LIP TREATMENT & PROTECTANT

NET WT 5g / .17 OZ

SPF 21
SUNSCREEN

Principal Display Panel (5 g Cylinder Label)

Principal Display Panel (5 g Cylinder Label)

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