RESILIENCE LIFT FIRMING/SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 NML/COMBO- octinoxate and titanium dioxide lotion

RESILIENCE LIFT FIRMING/SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 NML/COMBO by

Drug Labeling and Warnings

RESILIENCE LIFT FIRMING/SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 NML/COMBO by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 7.50%	Sunscreen
Titanium Dioxide 1.70%	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 cetyl ethylhexanoate butylene glycol octyldodecyl neopentanoate glyceryl stearate peg-100 stearate glycerin polyethylene hydrogenated lecithin pentylene glycol laminaria digitata extract behenyl alcohol algae extract persea gratissima (avocado) oil cucumis melo (melon) fruit extract potassium hydroxide mimosa tenuiflora bark extract yeast extract\faex\extrait de levure aminopropyl ascorbyl phosphate thermus thermophillus ferment saccharomyces ferment lysate filtrate artemia extract acetyl glucosamine linoleic acid lecithin whey protein\lactis protein\proteine du petit-lait tocopheryl acetate caffeine ergothioneine polymethyl methacrylate sodium hyaluronate decarboxy carnosine hcl stearic acid zinc pca trehalose cholesterol sorbitol acetyl hexapeptide-8 potassium sulfate citric acid hydrogenated starch hydrolysate plankton extract propylene glycol dicaprylate maltodextrin malachite hexylene glycol ethylhexylglycerin caprylyl glycol carbomer silica alumina fragrance (parfum) xanthan gum disodium edta bht phenoxyethanol potassium sorbate sodium dehydroacetate mica titanium dioxide (ci 77891) iron oxides (ci 77491, ci 77492, ci 77499) <iln38995>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

ESTĒE LAUDER

Resilience Lift
Firming/Sculpting
Face and Neck Lotion
Broad Spectrum
SPF 15

Normal/Combination Skin
1.7 FL. OZ. LIQ./50 ml e

INGREDIENTS AND APPEARANCE

RESILIENCE LIFT FIRMING/SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 NML/COMBO 
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0765 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01734 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
DOCOSANOL (UNII: 9G1OE216XY)
AVOCADO OIL (UNII: 6VNO72PFC1)
MUSKMELON (UNII: ZV095H5633)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
WHEY (UNII: 8617Z5FMF6)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAFFEINE (UNII: 3G6A5W338E)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)
STEARIC ACID (UNII: 4ELV7Z65AP)
ZINC PIDOLATE (UNII: C32PQ86DH4)
TREHALOSE (UNII: B8WCK70T7I)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SORBITOL (UNII: 506T60A25R)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
POTASSIUM SULFATE (UNII: 1K573LC5TV)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 11559-025-01	1 in 1 CARTON	09/01/2010
1		50 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	09/01/2010

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-025) , REPACK(11559-025)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-025)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-025)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-025)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-025)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-025) , REPACK(11559-025)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-025) , REPACK(11559-025)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-025)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-025)