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

Covergirl Vitalist Healthy Foundation with Vitamins plus Ensulizole Sunscreen Broad Spectrum SPF 20 (All shades) by

Drug Labeling and Warnings

Covergirl Vitalist Healthy Foundation with Vitamins plus Ensulizole Sunscreen Broad Spectrum SPF 20 (All shades) by is a Otc medication manufactured, distributed, or labeled by Noxell Corporation, COTY US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Noxell Corporation (003082997)

Registrant - COTY US LLC (039056361)

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