ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36- octinoxate, titanium dioxide and zinc oxide gel

ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36 by

Drug Labeling and Warnings

ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER 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 INGREDIENT

Active ingredients	Purpose
Octinoxate 6.8%	Sunscreen
Titanium Dioxide 7.6%	Sunscreen
Zinc Oxide 3.6%	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 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∙phenyl trimethicone∙dimethicone∙pentaerythrityl tetraisostearate∙methyl trimethicone∙glycerin∙propanediol∙lauryl peg-9 polydimethylsiloxyethyl dimethicone∙silica∙isohexadecane∙cetyl peg/ppg-10/1 dimethicone∙hydroxyethyl urea∙sapindus mukorossi fruit extract∙sodium hyaluronate∙tremella fuciformis sporocarp extract∙glycine soja (soybean) seed extract∙laminaria saccharina extract∙lactobacillus ferment∙trehalose∙dimethicone/vinyl dimethicone crosspolymer∙caprylyl glycol∙diisostearyl malate∙caffeine∙linoleic acid∙phospholipids∙polyglyceryl-2 triisostearate∙caprylic/capric triglyceride∙phytosteryl canola glycerides∙triolein∙tocopheryl acetate∙hydrogenated coco-glycerides∙methicone∙caesalpinia spinosa gum∙jojoba esters∙acetyl hexapeptide-8∙peg-75∙triethoxycaprylylsilane∙alumina∙disteardimonium hectorite∙propylene carbonate∙betaine∙dimethicone silylate∙tocopherol∙dimethicone/peg-10/15 crosspolymer∙magnesium sulfate∙palmitic acid∙oleic acid∙polymethylsilsesquioxane∙butylene glycol∙dipropylene glycol∙stearic acid∙polysilicone-11∙sodium citrate∙glyceryl stearate∙stearyl alcohol∙cetearyl alcohol∙ammonium polyacryloyldimethyl taurate∙polysorbate 80∙trimethylsiloxysilicate∙polysorbate 20∙behenyl alcohol∙dimethicone/divinyldimethicone silsesquioxane crosspolymer∙fragrance (parfum)∙linalool∙limonene∙alpha-isomethyl ionone∙disodium edta∙bht∙phenoxyethanol∙potassium sorbate∙[+/- titanium dioxide (ci 77891)∙iron oxides (ci 77492)∙iron oxides (ci 77491)∙iron oxides (ci 77499)∙mica] <iln49800>

Other information

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

PRINCIPAL DISPLAY PANEL - 28 g Cartridge Carton

ESTĒE LAUDER

Double Wear
Soft Glow Matte
Cushion Makeup
Broad Spectrum SPF 36

Plus 1 Refill

TOTAL POIDS NET WT. .98 OZ./28g ℮ (14g X2)

INGREDIENTS AND APPEARANCE

ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36 
octinoxate, titanium dioxide and zinc oxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-062
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	68 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	76 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	36 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CANOLA OIL (UNII: 331KBJ17RK)
GLYCERYL TRIOLEATE (UNII: O05EC62663)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
METHICONE (20 CST) (UNII: 6777U11MKT)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
PEG-75 DILAURATE (UNII: K881554QIN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM OXIDE (UNII: LMI26O6933)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BETAINE (UNII: 3SCV180C9W)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PALMITIC ACID (UNII: 2V16EO95H1)
OLEIC ACID (UNII: 2UMI9U37CP)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER (UNII: T3064TZ75A)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
LINALOOL, (+)- (UNII: F4VNO44C09)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
SOYBEAN (UNII: L7HT8F1ZOD)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
CAFFEINE (UNII: 3G6A5W338E)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
PHOSPHOLIPID PHOSPHATASE 1 (UNII: IP029363WQ)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-062-01	1 in 1 CARTON	07/07/2021	12/31/2023
1		28 g in 1 CARTRIDGE; Type 0: Not a Combination Product
2	NDC: 11559-062-02	1 in 1 CARTON	12/21/2023
2		24 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/07/2021

Labeler - ESTEE LAUDER INC (005914387)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder N.V.		370151326	manufacture(11559-062) , pack(11559-062) , label(11559-062)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX INC		689049693	manufacture(11559-062)