SKIN FOUNDATION CUSHION COMPACT BROAD SPECTRUM SPF 35- octinoxate, octisalate, and titanium dioxide paste

SKIN FOUNDATION CUSHION COMPACT BROAD SPECTRUM SPF 35 by

Drug Labeling and Warnings

SKIN FOUNDATION CUSHION COMPACT BROAD SPECTRUM SPF 35 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., Kolmar Korea Co., Ltd., PALC, Estee Lauder Cosmetics Ltd., Northtec LLC, PADC 1, Len-Ron Manufacturing Division of Aramis Inc., Whitman Laboratories Ltd., Estee Lauder N.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 7.0%
Octisalate 4.5%
Titanium Dioxide 4.2%

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 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 talc butyloctyl salicylate caprylyl methicone butylene glycol dipropylene glycol lauryl peg-9 polydimethylsiloxyethyl dimethicone coco-caprylate/caprate butylene glycol dicaprylate/dicaprate dimethicone polyglyceryl-6 polyricinoleate albizia julibrissin bark extract lavandula angustifolia (lavender) oil litchi chinensis seed extract pelargonium graveolens (geranium) flower oil laminaria saccharina extract cucumis sativus (cucumber) fruit extract scutellaria baicalensis root extract pyrus malus (apple) fruit extract glycyrrhetinic acid oryzanol caffeine trehalose glycerin sodium hyaluronate ethylhexylglycerin acetyl hexapeptide-8 disteardimonium hectorite tocopheryl acetate sucrose aluminum stearate aminopropyl dimethicone polymethylsilsesquioxane cholesterol peg-10 dimethicone palmitic acid dimethicone crosspolymer sodium pca urea triethoxycaprylylsilane tocopherol dextrin polyquaternium-51 polyurethane-11 magnesium sulfate potassium sorbate sodium benzoate tetrahexyldecyl ascorbate aluminum hydroxide alumina sorbic acid silica disodium edta bht linalool geraniol citronellol phenoxyethanol chlorphenesin [+/- mica titanium dioxide (ci 77891) zinc oxide (ci 77947) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499)] <iln42837>

Other information

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

PRINCIPAL DISPLAY PANEL - 13 g Container Carton

BOBBI BROWN

Skin Foundation Cushion Compact
Broad Spectrum SPF 35

Protect & Recharge

NET WT. .45 OZ./13 g e

INGREDIENTS AND APPEARANCE

SKIN FOUNDATION CUSHION COMPACT BROAD SPECTRUM SPF 35 
octinoxate, octisalate, and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
phenyl trimethicone (UNII: DR0K5NOJ4R)
talc (UNII: 7SEV7J4R1U)
butyloctyl salicylate (UNII: 2EH13UN8D3)
caprylyl trisiloxane (UNII: Q95M2P1KJL)
butylene glycol (UNII: 3XUS85K0RA)
dipropylene glycol (UNII: E107L85C40)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
coco-caprylate/caprate (UNII: 8D9H4QU99H)
butylene glycol dicaprylate/dicaprate (UNII: 75D21FL1PI)
dimethicone (UNII: 92RU3N3Y1O)
albizia julibrissin bark (UNII: 0J9G6W44DV)
lavender oil (UNII: ZBP1YXW0H8)
litchi chinensis seed (UNII: 9294024N9Q)
pelargonium graveolens flower oil (UNII: 3K0J1S7QGC)
saccharina latissima (UNII: 68CMP2MB55)
cucumber (UNII: YY7C30VXJT)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
apple (UNII: B423VGH5S9)
enoxolone (UNII: P540XA09DR)
gamma oryzanol (UNII: SST9XCL51M)
caffeine (UNII: 3G6A5W338E)
trehalose (UNII: B8WCK70T7I)
glycerin (UNII: PDC6A3C0OX)
hyaluronate sodium (UNII: YSE9PPT4TH)
ethylhexylglycerin (UNII: 147D247K3P)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
disteardimonium hectorite (UNII: X687XDK09L)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
sucrose (UNII: C151H8M554)
aluminum stearate (UNII: U6XF9NP8HM)
cholesterol (UNII: 97C5T2UQ7J)
peg-10 dimethicone (600 cst) (UNII: 8PR7V1SVM0)
palmitic acid (UNII: 2V16EO95H1)
dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) (UNII: UF7620L1W6)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
urea (UNII: 8W8T17847W)
triethoxycaprylylsilane (UNII: LDC331P08E)
tocopherol (UNII: R0ZB2556P8)
icodextrin (UNII: 2NX48Z0A9G)
magnesium sulfate, unspecified form (UNII: DE08037SAB)
potassium sorbate (UNII: 1VPU26JZZ4)
sodium benzoate (UNII: OJ245FE5EU)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
aluminum hydroxide (UNII: 5QB0T2IUN0)
aluminum oxide (UNII: LMI26O6933)
sorbic acid (UNII: X045WJ989B)
silicon dioxide (UNII: ETJ7Z6XBU4)
edetate disodium (UNII: 7FLD91C86K)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
linalool, (+/-)- (UNII: D81QY6I88E)
geraniol (UNII: L837108USY)
.beta.-citronellol, (R)- (UNII: P01OUT964K)
phenoxyethanol (UNII: HIE492ZZ3T)
chlorphenesin (UNII: I670DAL4SZ)
mica (UNII: V8A1AW0880)
zinc oxide (UNII: SOI2LOH54Z)
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: 64141-023-01	1 in 1 CARTON	05/16/2016
1		13 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	05/16/2016

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-023) , REPACK(64141-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-023)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-023)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-023) , REPACK(64141-023)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-023) , REPACK(64141-023)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-023)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	MANUFACTURE(64141-023)