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

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 WATER DIMETHICONE 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 LACTOBACILLUS 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

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 NOT FINAL part352 10/16/2019

Labeler — Bobbi Brown Professional Cosmetics Inc. (627131279)

Registrant — Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Operations
Whitman Laboratories Ltd.		216866277	MANUFACTURE (64141-030), REPACK (64141-030), RELABEL (64141-030)

Establishment
Name	Address	ID/FEI	Operations
ESTEE LAUDER COMPANY, THE		828534516	REPACK (64141-030), RELABEL (64141-030)

Establishment
Name	Address	ID/FEI	Operations
Estee Lauder Cosmetics Ltd.		202952982	MANUFACTURE (64141-030), REPACK (64141-030), RELABEL (64141-030)

Establishment
Name	Address	ID/FEI	Operations
Estee Lauder Cosmetics Ltd.		204132062	REPACK (64141-030), RELABEL (64141-030)

Establishment
Name	Address	ID/FEI	Operations
Estee Lauder N.V.		370151326	MANUFACTURE (64141-030), REPACK (64141-030), RELABEL (64141-030)

Establishment
Name	Address	ID/FEI	Operations
NORTHTEC INC		943871157	REPACK (64141-030), RELABEL (64141-030)

Establishment
Name	Address	ID/FEI	Operations
NORTHTEC PALC		102631997	REPACK (64141-030), RELABEL (64141-030)

Establishment
Name	Address	ID/FEI	Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	MANUFACTURE (64141-030), REPACK (64141-030), RELABEL (64141-030)

Establishment
Name	Address	ID/FEI	Operations
PADC 1		949264774	REPACK (64141-030), RELABEL (64141-030)

Revised: 08/2021 Bobbi Brown Professional Cosmetics Inc.