ELEVEN PERFECT FORM TINTED LIP BALM VENUS- 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 ingredients

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 7, Aluminum Hydroxide, Curcuma Longa (Turmeric) Root Extract, Acacia Senegal Gum, Maltodextrin, Beta Vulgaris (Beet) Root Extract, Citric Acid, Ascorbic Acid, Ipomoea Batatas Root Extract, Red 6, 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

DIST. BY CYBERDERM LABORATORIES

650-1600 CARLING AVE

OTTAWA ON CANADA K1Z 1G3

MADE IN CANADA

PRINCIPAL DISPLAY PANEL

ELEVEN BY VENUS
PERFECT FORM TINTED LIP BALM
SPF 15

100% Mineral Broad Spectrum
VENUS

20% Zinc Oxide

Sunscreen Lip Balm

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

INGREDIENTS AND APPEARANCE

ELEVEN PERFECT FORM TINTED LIP BALM  VENUS
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71644-015
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
MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M)
TURMERIC (UNII: 856YO1Z64F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
BEET (UNII: N487KM8COK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
D&C RED NO. 6 (UNII: 481744AI4O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
SHEA BUTTER (UNII: K49155WL9Y)
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)
SWEET POTATO (UNII: M9WGG9Z9GK)
ACACIA (UNII: 5C5403N26O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71644-015-10	1 in 1 CARTON	01/14/2021
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	01/14/2021

Labeler - Cyberderm Laboratories inc. (242524267)