SKIN LONG-WEAR FLUID POWDER FOUNDATION BROAD SPECTRUM SPF 20- ensulizole, titanium dioxide, and zinc oxide liquid

SKIN LONG-WEAR FLUID powder FOUNDATION BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

SKIN LONG-WEAR FLUID powder FOUNDATION BROAD SPECTRUM SPF 20 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.022 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.041 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
methyl trimethicone (UNII: S73ZQI0GXM)
calcium aluminum borosilicate (UNII: 3JRB8A35M0)
polymethylsilsesquioxane (4.5 microns) (UNII: 59Z907ZB69)
isopentyldiol (UNII: 19NOL5474Q)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
hydrated silica (UNII: Y6O7T4G8P9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WHEY (UNII: 8617Z5FMF6)
isononyl isononanoate (UNII: S4V5BS6GCX)
LACTOBACILLUS REUTERI (UNII: 9913I24QEE)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
hyaluronate sodium (UNII: YSE9PPT4TH)
disodium stearoyl glutamate (UNII: 45ASM2L11M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
serine (UNII: 452VLY9402)
aspartic acid (UNII: 30KYC7MIAI)
glutamic acid (UNII: 3KX376GY7L)
leucine (UNII: GMW67QNF9C)
alanine (UNII: OF5P57N2ZX)
lysine (UNII: K3Z4F929H6)
trisiloxane (UNII: 9G1ZW13R0G)
arginine (UNII: 94ZLA3W45F)
phenylalanine (UNII: 47E5O17Y3R)
tyrosine (UNII: 42HK56048U)
histidine (UNII: 4QD397987E)
isoleucine (UNII: 04Y7590D77)
threonine (UNII: 2ZD004190S)
proline (UNII: 9DLQ4CIU6V)
triethyl citrate (UNII: 8Z96QXD6UM)
valine (UNII: HG18B9YRS7)
butylene glycol (UNII: 3XUS85K0RA)
caprylyl glycol (UNII: 00YIU5438U)
triethoxycaprylylsilane (UNII: LDC331P08E)
aluminum dimyristate (UNII: J2KA067N9O)
disteardimonium hectorite (UNII: X687XDK09L)
tromethamine (UNII: 023C2WHX2V)
sodium chloride (UNII: 451W47IQ8X)
glycine (UNII: TE7660XO1C)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-030-01	1 in 1 CARTON	10/16/2019
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

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)

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

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-030)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-030)

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

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

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-030)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-030)