SUPER LYSINE PLUS TANGERINE LIP TREATMENT- octinoxate and oxybenzone lipstick

Super Lysine Plus Tangerine Lip Treatment by

Drug Labeling and Warnings

Super Lysine Plus Tangerine Lip Treatment by is a Otc medication manufactured, distributed, or labeled by Quantum, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
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.

• Do not use on damaged or broken skin.

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

• 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).

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

SUPER LYSINE PLUS TANGERINE LIP TREATMENT 
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70084-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	70 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Yellow Wax (UNII: 2ZA36H0S2V)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Echinacea Purpurea (UNII: QI7G114Y98)
BENZOIN RESIN (UNII: GK21SBA74R)
GOLDENSEAL (UNII: ZW3Z11D0JV)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
TEA TREE OIL (UNII: VIF565UC2G)
MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SAFFLOWER (UNII: 4VBL71TY4Y)
Cholecalciferol (UNII: 1C6V77QF41)
CARNAUBA WAX (UNII: R12CBM0EIZ)
Water (UNII: 059QF0KO0R)
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL (UNII: 724GKU717M)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	WHITE (Brownish-White)	Score
Shape		Size
Flavor	TANGERINE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70084-230-01	5 g in 1 CYLINDER; Type 0: Not a Combination Product	04/02/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/02/2001

Labeler - Quantum, Inc. (044806305)