DOUBLE WEAR CUSHION BB ALL DAY WEAR COMPACT BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide paste

DOUBLE WEAR CUSHION BB ALL DAY WEAR COMPACT BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

DOUBLE WEAR CUSHION BB ALL DAY WEAR COMPACT BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., Nippon Shikizai,inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 7.6 %	Sunscreen
Zinc Oxide 5.1%	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 dimethicone butyloctyl salicylate isononyl isononanoate octyldodecyl neopentanoate butylene glycol phenyl trimethicone lauryl peg-9 polydimethylsiloxyethyl dimethicone diethylhexyl succinate methyl trimethicone silica dimethicone silylate tocopheryl acetate dipentaerythrityl tri-polyhydroxystearate magnesium sulfate porphyra yezoensis (algae) extract laminaria saccharina extract lens esculenta (lentil) fruit extract silk powder\serica\poudre de soie litchi chinensis seed extract palmaria palmata extract pyrus malus (apple) fruit extract citrullus vulgaris (watermelon) fruit extract acetyl hexapeptide-8 caffeine caprylyl methicone tourmaline sodium lactate thermus thermophillus ferment cetyl peg/ppg-10/1 dimethicone ascorbyl glucoside glycerin hydrolyzed wheat protein/pvp crosspolymer triethoxycaprylylsilane caprylyl glycol sodium pca polyhydroxystearic acid sodium hyaluronate dimethicone crosspolymer-3 dipropylene glycol laureth-4 dimethicone/peg-10/15 crosspolymer dextrin sodium benzoate citric acid pentylene glycol phenoxyethanol chlorphenesin [+/- mica titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499)] <iln42860>

Other information

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

PRINCIPAL DISPLAY PANEL - 12 g Container Carton

ESTĒE LAUDER

Double Wear
Cushion

BB

All Day Wear Liquid Compact
Broad Spectrum SPF 50

NET WT. .42 OZ./12g e

INGREDIENTS AND APPEARANCE

DOUBLE WEAR CUSHION BB ALL DAY WEAR COMPACT BROAD SPECTRUM SPF 50 
titanium dioxide and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
DULSE (UNII: 7832HOY4ZQ)
APPLE (UNII: B423VGH5S9)
WATERMELON (UNII: 231473QB6R)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
CAFFEINE (UNII: 3G6A5W338E)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
SODIUM LACTATE (UNII: TU7HW0W0QT)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LAURETH-4 (UNII: 6HQ855798J)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-047-01	1 in 1 CARTON	07/01/2016
1		12 g in 1 CONTAINER; 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	07/01/2016

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-047) , REPACK(11559-047)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-047)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-047)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-047)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-047)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-047) , REPACK(11559-047)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-047) , REPACK(11559-047)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-047)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-047)

Establishment
Name	Address	ID/FEI	Business Operations
Nippon Shikizai,inc.		694869178	MANUFACTURE(11559-047)