Drug Labeling and Warnings

Drug Details

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 22700-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 22700-200-3030 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2017
Labeler - Noxell Corporation (003082997)
Registrant - COTY US LLC (039056361)
Establishment
NameAddressID/FEIBusiness Operations
Noxell Corporation003082997manufacture(22700-200)

Revised: 2/2019
 
Noxell Corporation


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