Drug Facts

Active ingredient

Ensulizole 3%.

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If product is 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
use water resistant sunscreen if swimming or sweating
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 sun, especially from 10 a.m. – 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
children under 6 months: ask a doctor

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

Water, cyclopentasiloxane, propylene glycol, glycerin, titanium dioxide, dimethicone, talc, aluminum starch octenylsuccinate, peg/ppg-18/18 dimethicone, pvp, sodium chloride, phenoxyethanol, sodium hydroxide, trihydroxystearin, arachidyl behenate, caprylyl glycol, 1,2-hexanediol, methicone, fragrance, sodium benzoate, silica, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, synthetic wax, polyglyceryl-4 isostearate, hexyl laurate, cetyl peg/ppg-10/1 dimethicone, tocopheryl acetate, panthenol, niacinamide, ethylene brassylate, behenic acid, polyethylene, isopropyl titanium triisostearate, iron oxides

Questions?

Call 1-800-426-8374

MADE IN USAOF US & IMPORTED PARTS

COTYUS LLC, NEW YORK, NY 10118

Principal Display Panel - Covergirl Vitalist Healthy Elixir Label

COVERGIRL

vitalist

HEALTHY

ELIXIR

FOUNDATION WITH VITAMINS +
ENSULIZOLE SUNSCREEN
BROAD SPECTRUM SPF 20

705

30 mL (1 FL OZ)

Principal Display Panel - Covergirl Vitalist Healthy Elixir Label

COVERGIRL VITALIST HEALTHY FOUNDATION WITH VITAMINS PLUS ENSULIZOLE SUNSCREEN BROAD SPECTRUM SPF 20 (ALL SHADES)
ensulizole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:22700-200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE (UNII: 92RU3N3Y1O)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
ARACHIDYL BEHENATE (UNII: 9G00Q0O2NS)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
METHICONE (20 CST) (UNII: 6777U11MKT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
NIACINAMIDE (UNII: 25X51I8RD4)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
BEHENIC ACID (UNII: H390488X0A)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:22700-200-30	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/01/2017

Labeler - Noxell Corporation (003082997)

Registrant - COTY US LLC (039056361)

Name	Address	ID/FEI	Business Operations
Establishment
Noxell Corporation		003082997	manufacture(22700-200)