Eleven Perfect Form Tinted Lip Balm Power Player: Package Insert and Label Information

ELEVEN PERFECT FORM TINTED LIP BALM POWER PLAYER- zinc oxide cream
Cyberderm Laboratories inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

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.

Directions

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

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

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 or Comments?
718-481-2628.

MADE IN COLLABORATION WITH THE SUNSCREEN COMPANY™

DIST. BY CYBERDERM LABORATORIES

650-1600 CARLING AVE

OTTAWA ON CANADA K1Z 1G3

MADE IN CANADA

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.

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC CATION) ZINC CATION 20 g in 100 mL

Inactive Ingredients Ingredient Name Strength AMMONIUM GLYCYRRHIZATE ALUMINUM HYDROXIDE D&C RED NO. 6 POLYHYDROXYSTEARIC ACID (2300 MW) .ALPHA.-TOCOPHEROL, D- MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL ISOSTEARATE SHEA BUTTER MORELLA CERIFERA FRUIT WAX SODIUM STEAROYL LACTYLATE CANDELILLA WAX LAURYL LAURATE BEHENYL BEHENATE POLYGLYCERYL-10 STEARATE CORN OIL HYDROGENATED PALM OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71644-014-10 1 TUBE in 1 CARTON contains a TUBE 1 10 mL in 1 TUBE This package is contained within the CARTON (71644-014-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/18/2020

Labeler — Cyberderm Laboratories inc. (242524267)

Revised: 01/2023 Cyberderm Laboratories inc.