ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19- octinoxate and titanium dioxide liquid

ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19 by

Drug Labeling and Warnings

ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., Len-Ron Manufacturing Division of Aramis Inc., Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., PALC, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 2.0%	Sunscreen
Titanium Dioxide 2.3%	Sunscreen

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

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 methyl trimethicone phenyl trimethicone dimethicone neopentyl glycol diheptanoate polymethylsilsesquioxane silica lauryl peg-9 polydimethylsiloxyethyl dimethicone c12-15 alkyl benzoate butylene glycol butyloctyl salicylate trimethylsiloxysilicate glycerin peg-10 dimethicone polysilicone-11 laminaria saccharina extract litchi chinensis seed extract citrullus lanatus (watermelon) fruit extract pyrus malus (apple) fruit extract sodium hyaluronate lens esculenta (lentil) fruit extract polyglutamic acid methicone tocopheryl acetate caprylyl glycol triethyl citrate thermus thermophillus ferment sodium lactate sodium pca tocopherol lecithin dimethicone/peg-10/15 crosspolymer c24-28 alkyl methicone dimethicone silylate disteardimonium hectorite zinc stearate sodium chloride hexylene glycol laureth-7 magnesium aluminum silicate dextrin xanthan gum dipropylene glycol bht disodium edta sodium citrate potassium sorbate sodium dehydroacetate sodium benzoate phenoxyethanol [+/- titanium dioxide (ci 77891) iron oxides (ci 77491) iron oxides (ci 77492) iron oxides (ci 77499)] <iln48777>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

ESTĒE LAUDER

Double Wear
Sheer Long-Wear Makeup
Broad Spectrum SPF 19

1 FL. OZ. LIQ. /30ml e

INGREDIENTS AND APPEARANCE

ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
WATERMELON (UNII: 231473QB6R)
APPLE (UNII: B423VGH5S9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
PACLITAXEL POLIGLUMEX (UNII: TQ64FZ98ZN)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
THERMUS THERMOPHILUS (UNII: 415H64SACF)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
C24-28 OLEFIN (UNII: 6P4501CWYB)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ZINC STEARATE (UNII: H92E6QA4FV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
XANTHAN GUM (UNII: TTV12P4NEE)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 11559-061-01	1 in 1 CARTON	01/07/2021
1		30 mL in 1 BOTTLE; 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	01/07/2021

Labeler - ESTEE LAUDER INC (005914387)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture(11559-061) , pack(11559-061) , label(11559-061)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		202952982	manufacture(11559-061) , pack(11559-061) , label(11559-061)

Establishment
Name	Address	ID/FEI	Business Operations
Whitman Laboratories Ltd.		216866277	manufacture(11559-061) , pack(11559-061) , label(11559-061)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder N.V.		370151326	manufacture(11559-061) , pack(11559-061) , label(11559-061)

Establishment
Name	Address	ID/FEI	Business Operations
PALC		078364654	pack(11559-061) , label(11559-061)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	pack(11559-061) , label(11559-061)

Establishment
Name	Address	ID/FEI	Business Operations
Northtec LLC		943871157	pack(11559-061) , label(11559-061)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	pack(11559-061) , label(11559-061)