SPL v8
SPL
SPL Set ID 5e719401-4165-4958-87ab-cf8452e08b36
Route
TOPICAL
Published
Effective Date 2018-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (0.03 mg)
Inactive Ingredients
Water Cyclomethicone 5 Propylene Glycol Talc Dimethicone Aluminum Starch Octenylsuccinate Sodium Chloride Peg/ppg-18/18 Dimethicone Benzyl Alcohol Phenoxyethanol Sodium Hydroxide Trihydroxystearin Arachidyl Behenate Silicon Dioxide Sodium Benzoate Hexyl Laurate Polyglyceryl-4 Isostearate Isopropyl Titanium Triisostearate Ethylene Brassylate Behenic Acid High Density Polyethylene Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-09-01 Until 2021-12-31

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children.

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

Section 50566-9
  • Stop use and ask a doctor if rash occurs
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove
Section 50570-1
  • Do not use on damaged or broken skin
Warnings
  • For external use only
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
Questions?

Call 1-800-426-8374

Active Ingredient

Ensulizole 3%

Other Information
  • protect this product from excessive heat and direct sun
Inactive Ingredients

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

Principal Display Panel Covergirl Queen Collection All Day 800 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q800

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 805 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q805

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 810 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q810

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 815 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q815

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 820 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q820

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 825 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q825

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 830 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q830

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 835 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q835

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 840 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q840

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 845 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q845

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 850 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q850

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 855 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q855

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 860 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q860

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 865 Label

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q865

30 mL (1 FL OZ)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children.

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

Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
Purpose

Sunscreen

Warnings
  • For external use only
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
Questions?

Call 1-800-426-8374

Active Ingredient (Active ingredient)

Ensulizole 3%

Other Information (Other information)
  • protect this product from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel Covergirl Queen Collection All Day 800 Label (Principal Display Panel - Covergirl Queen Collection All Day 800 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q800

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 805 Label (Principal Display Panel - Covergirl Queen Collection All Day 805 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q805

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 810 Label (Principal Display Panel - Covergirl Queen Collection All Day 810 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q810

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 815 Label (Principal Display Panel - Covergirl Queen Collection All Day 815 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q815

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 820 Label (Principal Display Panel - Covergirl Queen Collection All Day 820 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q820

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 825 Label (Principal Display Panel - Covergirl Queen Collection All Day 825 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q825

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 830 Label (Principal Display Panel - Covergirl Queen Collection All Day 830 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q830

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 835 Label (Principal Display Panel - Covergirl Queen Collection All Day 835 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q835

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 840 Label (Principal Display Panel - Covergirl Queen Collection All Day 840 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q840

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 845 Label (Principal Display Panel - Covergirl Queen Collection All Day 845 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q845

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 850 Label (Principal Display Panel - Covergirl Queen Collection All Day 850 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q850

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 855 Label (Principal Display Panel - Covergirl Queen Collection All Day 855 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q855

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 860 Label (Principal Display Panel - Covergirl Queen Collection All Day 860 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q860

30 mL (1 FL OZ)

Principal Display Panel Covergirl Queen Collection All Day 865 Label (Principal Display Panel - Covergirl Queen Collection All Day 865 Label)

COVERGIRL

QUEEN

COLLECTION

NEW LOOK

all day

FLAWLESS

3-IN-1

FOUNDATION + ENSULIZOLE SUNSCREEN

BROAD SPECTRUM SPF 20

Q865

30 mL (1 FL OZ)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)