OTC Medication Information: RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL OCTISALATE (OCTISALATE) OCTISALATE 45 mg in 1 mL OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 27 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER NEOPENTYL GLYCOL DIHEPTANOATE CETYL ALCOHOL GLYCERIN BUTYLOCTYL SALICYLATE PENTAERYTHRITYL TETRAETHYLHEXANOATE HIGH DENSITY POLYETHYLENE DI-C12-15 ALKYL FUMARATE PETROLATUM HYDROGENATED SOYBEAN LECITHIN BUTYLENE GLYCOL PROPANEDIOL HYDROGENATED POLYBUTENE (1300 MW) OCTYLDODECYL MYRISTATE HEXYLDECYL STEARATE DOCOSANOL MELON ACETYL HEXAPEPTIDE-8 MYELOPEROXIDASE GLUCOSE OXIDASE CHOLESTEROL PROPYLENE GLYCOL DICAPRYLATE AMINOPROPYL ASCORBYL PHOSPHATE HYALURONATE SODIUM ANHYDROUS DEXTROSE N-ACETYLGLUCOSAMINE GLYCERYL MONOSTEARATE AVOCADO DIMETHICONE C12-16 ALCOHOLS TREHALOSE ETHYLHEXYLGLYCERIN PEG-100 STEARATE CAFFEINE PALMITIC ACID SOY STEROL CAPRYLYL GLYCOL ISOHEXADECANE POLY(METHYL METHACRYLATE; 450000 MW) ZINC PIDOLATE POLYSORBATE 80 STARCH, POTATO DECARBOXY CARNOSINE HYDROCHLORIDE XANTHAN GUM SODIUM HYDROXIDE POTASSIUM SULFATE HEXYLENE GLYCOL EDETATE DISODIUM ANHYDROUS BUTYLATED HYDROXYTOLUENE POTASSIUM SORBATE PHENOXYETHANOL FD&C RED NO. 4 MICA TITANIUM DIOXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:11559-052-01 1 JAR in 1 CARTON contains a JAR 1 50 mL in 1 JAR This package is contained within the CARTON (11559-052-01)

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)

Registrant — Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Operations
Whitman Laboratories Ltd.		216866277	MANUFACTURE (11559-052), REPACK (11559-052), RELABEL (11559-052)

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

Establishment
Name	Address	ID/FEI	Operations
Estee Lauder Cosmetics Ltd.		202952982	MANUFACTURE (11559-052), REPACK (11559-052), RELABEL (11559-052)

Establishment
Name	Address	ID/FEI	Operations
Estee Lauder Cosmetics Ltd.		204132062	REPACK (11559-052), RELABEL (11559-052)

Establishment
Name	Address	ID/FEI	Operations
Estee Lauder N.V.		370151326	MANUFACTURE (11559-052), REPACK (11559-052), RELABEL (11559-052)

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

Establishment
Name	Address	ID/FEI	Operations
NORTHTEC PALC		102631997	REPACK (11559-052), RELABEL (11559-052)

Establishment
Name	Address	ID/FEI	Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	MANUFACTURE (11559-052), REPACK (11559-052), RELABEL (11559-052)

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

Revised: 07/2021 ESTEE LAUDER INC