Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen: Package Insert and Label Information

LANCOME PARIS HIGH RESOLUTION REFILL 3X TRIPLE ACTION RENEWAL ANTI WRINKLE BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octisalate and octocrylene cream
L’Oreal USA Products 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.

Active ingredients

Avobenzone 3%
Octisalate 5%
Octocrylene 3%

Purpose

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

● apply generously and evenly 15 minutes before sun exposure

● reapply at least every 2 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

Other information

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

Inactive ingredients

water, glycerin, dimethicone, PTFE, octyldodecanol, alcohol denat., isopropyl isostearate, methylsilanol/silicate crosspolymer, arachidyl alcohol, tocopheryl acetate, medicago sativa (alfalfa) extract, hydrolyzed rice protein, sodium chloride, sodium hyaluronate, phenoxyethanol, acetyl trifluoromethylphenyl valylglycine, adenosine, PEG-100 stearate, behenyl alcohol, polysorbate 80, silica, cellulose acetate butyrate, polyphosphorylcholine glycol acrylate, polyvinyl alcohol, dimethicone/vinyl dimethicone crosspolymer, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethiconol, limonene, ammonium polyacryloyldimethyl taurate, manganese gluconate, linalool, benzyl alcohol, isohexadecane, capryloyl salicylic acid, alpha-isomethyl ionone, acrylamide/sodium acryloyldimethyltaurate copolymer, carbomer, geraniol, disodium stearoyl glutamate, disodium EDTA, cetyl alcohol, cetearyl alcohol, methylparaen, cetearyl glucoside, butylphenyl methylpropional, methylisothiazolinone, citronellol, butylene glycol, coumarin, fragrance

Questions or comments?

1-800-LANCOME (1-800-526-2663)

Monday — Friday (9 a.m. — 5 p.m. EST)

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LANCOME PARIS HIGH RESOLUTION REFILL 3X TRIPLE ACTION RENEWAL ANTI WRINKLE BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone, octisalate and octocrylene cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-502
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (Avobenzone) Avobenzone 30 mg in 1 g
Octisalate (Octisalate) Octisalate 50 mg in 1 g
Octocrylene (Octocrylene) Octocrylene 30 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
DIMETHICONE
POLYTETRAFLUOROETHYLENE
OCTYLDODECANOL
ALCOHOL
ISOPROPYL ISOSTEARATE
ARACHIDYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE, D-
SODIUM CHLORIDE
HYALURONATE SODIUM
PHENOXYETHANOL
ACETYL TRIFLUOROMETHYLPHENYL VALYLGLYCINE, DL-
ADENOSINE
PEG-100 STEARATE
DOCOSANOL
POLYSORBATE 80
CELLABURATE (MW 12000, 32% BUTYRYL, 18% ACETYL)
POLYVINYL ALCOHOL (100000 MW)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)
DIMETHICONOL (100000 CST)
LIMONENE, (+)-
MANGANESE
GLUCONATE ION
LINALOOL, (+/-)-
BENZYL ALCOHOL
ISOHEXADECANE
CAPRYLOYL SALICYLIC ACID
ISOMETHYL-.ALPHA.-IONONE
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
GERANIOL
DISODIUM STEAROYL GLUTAMATE
EDETATE DISODIUM
CETYL ALCOHOL
CETOSTEARYL ALCOHOL
METHYLPARABEN
CETEARYL GLUCOSIDE
BUTYLPHENYL METHYLPROPIONAL
.BETA.-CITRONELLOL, (R)-
BUTYLENE GLYCOL
COUMARIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-502-01 1 JAR in 1 CARTON contains a JAR
1 75 g in 1 JAR This package is contained within the CARTON (49967-502-01)
2 NDC:49967-502-02 1 JAR in 1 CARTON contains a JAR
2 50 g in 1 JAR This package is contained within the CARTON (49967-502-02)
3 NDC:49967-502-03 1 JAR in 1 CARTON contains a JAR
3 15 g in 1 JAR This package is contained within the CARTON (49967-502-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/01/2013
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
SICOS ET CIE 276993581 manufacture (49967-502)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, Inc. 185931458 manufacture (49967-502)

Revised: 01/2020 L’Oreal USA Products Inc

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