Ensulizole

Manufacturer
Noxell Corporation | COTY US LLC
Effective date
2023-01-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:53:33

Label at a glance#

ProductCovergirl Vitalist Healthy Foundation with Vitamins plus Ensulizole Sunscreen Broad Spectrum SPF 20 (All shades)
Active ingredientENSULIZOLE
Label structure9 sections

Indications and 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

Dosage and administration

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 1...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ensulizole 3%.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use water resistant sunscreen if swimming or sweating
  • Sun Protection

SPL UNCLASSIFIED SECTION

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

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - Covergirl Vitalist Healthy Elixir Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
22700-200-302025-01-30C16284748780-12cef2736-6782-d83d-e063-dadaa90ab31f0543c8a4-6e13-4d01-b795-b24bf30bcabf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
22700-200-30Covergirl Vitalist Healthy Foundation with Vitamins plus Ensulizole Sunscreen Broad Spectrum SPF 20 (All shades)30 mL in 1 BOTTLE, PUMPLIQUID306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
22700-200COVERGIRL VITALIST HEALTHY FOUNDATION WITH VITAMINS PLUS ENSULIZOLE SUNSCREEN BROAD SPECTRUM SPF 20 (ALL SHADES) (ENSULIZOLE) LIQUID [NOXELL CORPORATION]6Legacy NDC, 1 package rows20230130_0543c8a4-6e13-4d01-b795-b24bf30bcabf.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
22700-20022700-200-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f3555124-f1c3-0391-e053-2995a90af2160543c8a4-6e13-4d01-b795-b24bf30bcabf2023-01-28WarningsExact identifier
spl id: f3555124-f1c3-0391-e053-2995a90af216
spl set id: 0543c8a4-6e13-4d01-b795-b24bf30bcabf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.