SKIN LONG-WEAR FLUID Powder FOUNDATION BROAD SPECTRUM SPF 20: Package Insert and Label Information

SKIN LONG-WEAR FLUID POWDER FOUNDATION BROAD SPECTRUM SPF 20- ensulizole, titanium dioxide and zinc oxide liquid
Bobbi Brown Professional Cosmetics Inc.

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.

Drug Facts

Active ingredients

Ensulizole 2.0%
Titanium Dioxide 3.7%
Zinc Oxide 1.8%

Purpose

Sunscreen

Use

helps prevent sunburn

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

For sunscreen use:

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every two hours
  • use a 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 the sun, especially from 10 a.m. — 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Inactive ingredients

water\aqua\eau ▪ dimethicone ▪ methyl trimethicone ▪ calcium aluminum borosilicate ▪ polymethylsilsesquioxane ▪ trimethylsiloxysilicate ▪ isopentyldiol ▪ hdi/ppg/polycaprolactone crosspolymer ▪ lauryl peg-9 polydimethylsiloxyethyl dimethicone ▪ hydrated silica ▪ peg-10 dimethicone ▪ dimethicone/vinyl dimethicone crosspolymer ▪ whey protein\lactis protein\proteine du petit-lait ▪ isononyl isononanoate ▪ lactobacillus ferment ▪ laminaria digitata extract ▪ sodium hyaluronate ▪ disodium stearoyl glutamate ▪ tocopheryl acetate ▪ serine ▪ aspartic acid ▪ glutamic acid ▪ leucine ▪ alanine ▪ lysine ▪ trisiloxane ▪ arginine ▪ phenylalanine ▪ tyrosine ▪ histidine ▪ isoleucine ▪ threonine ▪ proline ▪ triethyl citrate ▪ valine ▪ lecithin ▪ butylene glycol ▪ caprylyl glycol ▪ triethoxycaprylylsilane ▪ aluminum dimyristate ▪ disteardimonium hectorite ▪ tromethamine ▪ sodium chloride ▪ glycine ▪ magnesium sulfate ▪ silica ▪ disodium edta ▪ bht ▪ phenoxyethanol ▪ [+/- mica ▪ titanium dioxide (ci 77891) ▪ iron oxides (ci 77491) ▪ iron oxides (ci 77492) ▪ iron oxides (ci 77499)] <iln46506>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL — 40 ml Tube Carton

BOBBI
BROWN

Skin Long-Wear
Fluid Powder Foundation
Broad Spectrum
SPF 20

1.4 FL. OZ./40 ml e

PRINCIPAL DISPLAY PANEL -- 40 ml Tube Carton
(click image for full-size original)
SKIN LONG-WEAR FLUID POWDER FOUNDATION BROAD SPECTRUM SPF 20
ensulizole, titanium dioxide, and zinc oxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 0.022 g in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.041 g in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.02 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYL TRIMETHICONE
CALCIUM ALUMINUM BOROSILICATE
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
ISOPENTYLDIOL
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
HYDRATED SILICA
PEG-10 DIMETHICONE (600 CST)
WHEY
ISONONYL ISONONANOATE
LIMOSILACTOBACILLUS REUTERI
LAMINARIA DIGITATA
HYALURONATE SODIUM
DISODIUM STEAROYL GLUTAMATE
.ALPHA.-TOCOPHEROL ACETATE
SERINE
ASPARTIC ACID
GLUTAMIC ACID
LEUCINE
ALANINE
LYSINE
TRISILOXANE
ARGININE
PHENYLALANINE
TYROSINE
HISTIDINE
ISOLEUCINE
THREONINE
PROLINE
TRIETHYL CITRATE
VALINE
BUTYLENE GLYCOL
CAPRYLYL GLYCOL
TRIETHOXYCAPRYLYLSILANE
ALUMINUM DIMYRISTATE
DISTEARDIMONIUM HECTORITE
TROMETHAMINE
SODIUM CHLORIDE
GLYCINE
MAGNESIUM SULFATE, UNSPECIFIED FORM
SILICON DIOXIDE
EDETATE DISODIUM ANHYDROUS
BUTYLATED HYDROXYTOLUENE
PHENOXYETHANOL
MICA
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
WATER
DIMETHICONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64141-030-01 1 TUBE in 1 CARTON contains a TUBE
1 40 mL in 1 TUBE This package is contained within the CARTON (64141-030-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M020 10/16/2019
Labeler — Bobbi Brown Professional Cosmetics Inc. (627131279)
Registrant — Estee Lauder Companies Inc. (790802086)
Establishment
Name Address ID/FEI Operations
PALC 078364654 pack (64141-030), label (64141-030)
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Ltd. 204132062 pack (64141-030), label (64141-030)
Establishment
Name Address ID/FEI Operations
Northtec LLC 943871157 pack (64141-030), label (64141-030)
Establishment
Name Address ID/FEI Operations
PADC 1 949264774 pack (64141-030), label (64141-030)
Establishment
Name Address ID/FEI Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture (64141-030), pack (64141-030), label (64141-030)
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Ltd. 202952982 manufacture (64141-030), pack (64141-030), label (64141-030)
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 manufacture (64141-030), pack (64141-030), label (64141-030)
Establishment
Name Address ID/FEI Operations
Estee Lauder N.V. 370151326 manufacture (64141-030), pack (64141-030), label (64141-030)

Revised: 08/2022 Bobbi Brown Professional Cosmetics Inc.

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