RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene cream

RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., NORTHTEC INC, NORTHTEC PALC, Len-Ron Manufacturing Division of Aramis Inc., PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Octisalate 4.5%	Sunscreen
Octocrylene 2.7%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

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 and evenly 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 glycerin butyloctyl salicylate pentaerythrityl tetraethylhexanoate polyethylene di-c12-15 alkyl fumarate petrolatum hydrogenated lecithin butylene glycol propanediol hydrogenated polyisobutene octyldodecyl myristate hexyldecyl stearate behenyl alcohol cucumis melo (melon) fruit extract polygonum aviculare extract myrtus communis leaf extract laminaria digitata extract acetyl hexapeptide-8 tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate lactoperoxidase glucose oxidase cholesterol propylene glycol dicaprylate aminopropyl ascorbyl phosphate sodium hyaluronate glucose algae extract artemia extract acetyl glucosamine sigesbeckia orientalis (st. paul's wort) extract glyceryl stearate persea gratissima (avocado) oil dimethicone c12-16 alcohols trehalose ethylhexylglycerin peg-100 stearate caffeine palmitic acid glycine soja (soybean) sterols caprylyl glycol isohexadecane polymethyl methacrylate trifluoroacetyl tripeptide-2 tocopheryl acetate zinc pca polysilicone-11 polysorbate 80 yeast extract\faex\extrait de levure potato starch modified decarboxy carnosine hcl xanthan gum fragrance (parfum) sodium hydroxide potassium sulfate acrylamide/sodium acryloyldimethyltaurate copolymer dextran hexylene glycol disodium edta bht potassium sorbate phenoxyethanol red 4 (ci 14700) mica titanium dioxide (ci 77891) <iln44790>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ESTĒE LAUDER

Resilience Multi-Effect
Tri-Peptide Face and Neck Creme
Broad Spectrum SPF 15

Normal/Combination Skin

NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.045 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.027 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)
PETROLATUM (UNII: 4T6H12BN9U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)
HEXYLDECYL STEARATE (UNII: OJX2P28Y14)
DOCOSANOL (UNII: 9G1OE216XY)
MELON (UNII: 5CIT1X6U5V)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
MYELOPEROXIDASE (UNII: JQZ6YM58U5)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
AVOCADO (UNII: SDS87L369F)
DIMETHICONE (UNII: 92RU3N3Y1O)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
TREHALOSE (UNII: B8WCK70T7I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PEG-100 STEARATE (UNII: YD01N1999R)
CAFFEINE (UNII: 3G6A5W338E)
PALMITIC ACID (UNII: 2V16EO95H1)
SOY STEROL (UNII: PL360EPO9J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ZINC PIDOLATE (UNII: C32PQ86DH4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, POTATO (UNII: 8I089SAH3T)
DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM SULFATE (UNII: 1K573LC5TV)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-052-01	1 in 1 CARTON	11/01/2018
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	11/01/2018

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-052) , REPACK(11559-052)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-052)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-052)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-052)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-052)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-052) , REPACK(11559-052)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-052) , REPACK(11559-052)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-052)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-052)