ELEVEN UNRIVALED SUN SERUM- zinc oxide liquid

Eleven Unrivaled Sun Serum by

Drug Labeling and Warnings

Eleven Unrivaled Sun Serum 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 25%

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 and evenly to face and neck 15 minutes before sun exposure. Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENT

Inactive ingredients

Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Polylactic Acid, Coconut Alkanes, Coco-Caprylate/Caprate, Carthamus Tinctorius Oleasomes, Aqua, Opuntia Ficus-Incida Stem Extract (Prickly Pear), Cellulose, Sorbitan Oleate

OTHER SAFETY INFORMATION

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 value of SPF 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?
Call 718-481-2628

SPL UNCLASSIFIED SECTION

MADE IN COLLABORATION WITH THE SUNSCREEN COMPANY™

DIST. BY CYBERDERM LABORATORIES, 660-1600 CARLING AVE, OTTAWA ON K1Z 1G3

MADE IN CANADA

PRINCIPAL DISPLAY PANEL

ELEVEN BY VENUS

UNRIVALED SUN SERUM

SPF 35

100% Sheer Mineral Broad Spectrum

25% Zinc Oxide

Sunscreen Serum

UVA/UVB Protection

30 ML/1 FL. OZ.

INGREDIENTS AND APPEARANCE

ELEVEN UNRIVALED SUN SERUM 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71644-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYLACTIDE (UNII: 459TN2L5F5)
WATER (UNII: 059QF0KO0R)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
COCONUT ALKANES (UNII: 1E5KJY107T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71644-006-30	1 in 1 CARTON	01/26/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/26/2020

Labeler - Cyberderm Laboratories inc. (242524267)