RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 NML COMBO- avobenzone, octisalate, and octocrylene cream

RESILIENCE LIFT by

Drug Labeling and Warnings

RESILIENCE LIFT 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
Avobenzone 3.00 %	Sunscreen
Octisalate 5.00 %	Sunscreen
Octocrylene 2.70 %	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 neopentyl glycol diheptanoate cetyl alcohol pentaerythrityl tetraethylhexanoate glycerin polyethylene butyloctyl salicylate di-c12-15 alkyl fumarate petrolatum butylene glycol hydrogenated lecithin propanediol octyldodecyl myristate hexyldecyl stearate dimethicone laminaria saccharina extract algae extract mimosa tenuiflora bark extract plankton extract artemia extract laminaria digitata extract linoleic acid malachite chamomilla recutita (matricaria) saccharomyces ferment lysate filtrate acetyl hexapeptide-8 glyceryl stearate hydrogenated polyisobutene yeast extract\faex\extrait de levure c12-16 alcohols ethylhexylglycerin peg-100 stearate whey protein\lactis protein\proteine du petit-lait trehalose thermus thermophillus ferment ergothioneine hydrogenated starch hydrolysate acetyl glucosamine anthemis nobilis (chamomile) glucose oxidase lactoperoxidase caffeine cholesterol sorbitol palmitic acid decarboxy carnosine hcl glycine soja (soybean) sterols polysilicone-11 caprylyl glycol isohexadecane polymethyl methacrylate glucose zinc pca tocopheryl acetate behenyl alcohol citric acid sodium hyaluronate aminopropyl ascorbyl phosphate polysorbate 80 sodium hydroxide potassium sorbate maltodextrin acrylamide/sodium acryloyldimethyltaurate copolymer lecithin potato starch modified hexylene glycol xanthan gum disodium edta phenoxyethanol yellow 5 (ci 19140) red 4 (ci 14700) titanium dioxide (ci 77891) mica <iln39642>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

EL

ESTĒE LAUDER

Resilience Lift
Firming/Sculpting Face and Neck Creme
Oil-Free
Broad Spectrum SPF 15

Normal/Combination Skin

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

RESILIENCE LIFT   FIRMING SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 NML COMBO
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0303 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0505 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.2727 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
cetyl alcohol (UNII: 936JST6JCN)
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)
glycerin (UNII: PDC6A3C0OX)
high density polyethylene (UNII: UG00KM4WR7)
butyloctyl salicylate (UNII: 2EH13UN8D3)
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)
petrolatum (UNII: 4T6H12BN9U)
butylene glycol (UNII: 3XUS85K0RA)
propanediol (UNII: 5965N8W85T)
octyldodecyl myristate (UNII: S013N99GR8)
hexyldecyl stearate (UNII: OJX2P28Y14)
dimethicone (UNII: 92RU3N3Y1O)
saccharina latissima (UNII: 68CMP2MB55)
mimosa tenuiflora bark (UNII: 515MQE449I)
laminaria digitata (UNII: 15E7C67EE8)
linoleic acid (UNII: 9KJL21T0QJ)
matricaria chamomilla (UNII: G0R4UBI2ZZ)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
glyceryl monostearate (UNII: 230OU9XXE4)
yeast, unspecified (UNII: 3NY3SM6B8U)
c12-16 alcohols (UNII: S4827SZE3L)
ethylhexylglycerin (UNII: 147D247K3P)
peg-100 stearate (UNII: YD01N1999R)
trehalose (UNII: B8WCK70T7I)
ergothioneine (UNII: BDZ3DQM98W)
n-acetylglucosamine (UNII: V956696549)
chamaemelum nobile (UNII: 7NF3GE7IWR)
glucose oxidase (UNII: 0T8392U5N1)
caffeine (UNII: 3G6A5W338E)
cholesterol (UNII: 97C5T2UQ7J)
sorbitol (UNII: 506T60A25R)
palmitic acid (UNII: 2V16EO95H1)
decarboxy carnosine hydrochloride (UNII: 6X7K9I5QR7)
soy sterol (UNII: PL360EPO9J)
caprylyl glycol (UNII: 00YIU5438U)
isohexadecane (UNII: 918X1OUF1E)
dextrose, unspecified form (UNII: IY9XDZ35W2)
zinc pidolate (UNII: C32PQ86DH4)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
docosanol (UNII: 9G1OE216XY)
citric acid monohydrate (UNII: 2968PHW8QP)
hyaluronate sodium (UNII: YSE9PPT4TH)
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)
polysorbate 80 (UNII: 6OZP39ZG8H)
sodium hydroxide (UNII: 55X04QC32I)
potassium sorbate (UNII: 1VPU26JZZ4)
maltodextrin (UNII: 7CVR7L4A2D)
hexylene glycol (UNII: KEH0A3F75J)
xanthan gum (UNII: TTV12P4NEE)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
FD&C yellow no. 5 (UNII: I753WB2F1M)
FD&C red no. 4 (UNII: X3W0AM1JLX)
titanium dioxide (UNII: 15FIX9V2JP)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-029-01	1 in 1 CARTON	03/01/2013
1		50 mL in 1 JAR; 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	03/01/2013

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-029) , REPACK(11559-029)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-029)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-029)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-029)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-029)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-029) , REPACK(11559-029)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-029) , REPACK(11559-029)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-029)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-029)