ELEVEN PERFECT FORM TINTED LIP BALM POWER PLAYER- zinc oxide cream

Eleven Perfect Form Tinted Lip Balm by

Drug Labeling and Warnings

Eleven Perfect Form Tinted Lip Balm by is a Otc medication manufactured, distributed, or labeled by Cyberderm Laboratories inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide 20%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

• Helps prevent sunburn.

WARNINGS

Warnings

• 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.

• Keep out of reach of children.If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

INACTIVE INGREDIENT

Inactive ingredients

Caprylic/capric triglyceride, Butyrospermum Parkii (Shea) Butter, Myrica Cerifera (Bayberry) Fruit Wax, Vegetable Oil, Hydrogenated Vegetable Oil, Euphorbia Cerifera (Candelilla) Wax, Lauryl Laurate, Polyhydroxystearic Acid, Behenyl Behenate, Polyglyceryl-10 Stearate, Sodium Stearoyl Lactylate, Glyceryl Isostearate, Tocopherol. May contain: Red 6, Aluminum Hydroxide, Monoammonium Glycyrrhizinate

STORAGE AND HANDLING

Other information

• Protect this product from excessive heat and direct sun
• May stain some fabrics.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses
• Children under 6 months of age: ask a doctor

QUESTIONS

Questions or Comments?
718-481-2628.

SPL UNCLASSIFIED SECTION

MADE IN COLLABORATION WITH THE SUNSCREEN COMPANY™

DIST. BY CYBERDERM LABORATORIES

650-1600 CARLING AVE

OTTAWA ON CANADA K1Z 1G3

MADE IN CANADA

PRINCIPAL DISPLAY PANEL

ELEVEN

BY VENUS WILLIAMS
PERFECT FORM TINTED LIP BALM
SPF 15

100% Mineral Broad Spectrum
POWER PLAYER

20% Zinc Oxide

Sunscreen Lip Balm

UVA/UVB Protection
10ML / 0.34 FL. OZ.

INGREDIENTS AND APPEARANCE

ELEVEN PERFECT FORM TINTED LIP BALM  POWER PLAYER
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71644-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
D&C RED NO. 6 (UNII: 481744AI4O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
SHEA BUTTER (UNII: K49155WL9Y)
MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
CANDELILLA WAX (UNII: WL0328HX19)
LAURYL LAURATE (UNII: GPW77G0937)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
CORN OIL (UNII: 8470G57WFM)
HYDROGENATED PALM OIL (UNII: 257THB963H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71644-014-10	1 in 1 CARTON	06/19/2020
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/18/2020

Labeler - Cyberderm Laboratories inc. (242524267)