ELEVEN ON THE DEFENSE SUNSCREEN- zinc oxide lotion

Eleven On the Defense by

Drug Labeling and Warnings

Eleven On the Defense 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 25%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

• Helps prevent sunburn.

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

STOP USE

Stop use and ask a doctor if rash occurs.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

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 Aqua, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Polylactic Acid, Propanediol, Saccharomyces Ferment, Hydrogenated Sunflower Seed Oil Polyglyceryl-3 Esters, Hydrogenated Sunflower Seed Oil Glyceryl Esters, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Sorbitan Oleate, Acacia Senegal Gum, Cellulose, Caprylhydroxamic Acid, 1,2-Hexanediol, Xanthan Gum.

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?

Call 718-481-2628

SPL UNCLASSIFIED SECTION

MADE IN COLLABORATION WITH THE SUNSCREEN COMPANY™

DIST. BY: CYBERDERM LABORATORIES,

650-1600 CARLING AVENUE

OTTAWA, ON K1Z 1G3

MADE IN CANADA

PRINCIPAL DISPLAY PANEL

ELEVEN BY VENUS

ON-THE-DEFENSE SUNSCREEN

SPF 30

100% Sheer Mineral

Broad Spectrum

25% Zinc Oxide Sunscreen Lotion

UVA/UVB Protection

50 ml (1.7 FL. OZ.)

INGREDIENTS AND APPEARANCE

ELEVEN ON THE DEFENSE  SUNSCREEN
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71644-005
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
ACACIA (UNII: 5C5403N26O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYLACTIDE (UNII: 459TN2L5F5)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
WATER (UNII: 059QF0KO0R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
XANTHAN GUM (UNII: TTV12P4NEE)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
SUNFLOWER OIL MONO/DIGLYCERIDES (UNII: HS7EB0C1ZH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71644-005-50	1 in 1 CARTON	01/26/2020
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71644-005-05	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/26/2020

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)