Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 00:06:04

Label at a glance#

ProductLancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen
Active ingredientAvobenzone, Octisalate, Octocrylene
Label structure13 sections

Indications and 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

Dosage and administration

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 includ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%
Octisalate 5%
Octocrylene 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

- 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Monday - Friday (9 a.m. - 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-502-01Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen75 g in 1 JARCREAM7512
49967-502-01Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM112
49967-502-02Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM112
49967-502-02Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen50 g in 1 JARCREAM5012
49967-502-03Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM112
49967-502-03Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen15 g in 1 JARCREAM1512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-502LANCOME 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]12Current NDC, Legacy NDC, 6 package rows20231231_02c51b56-e39a-4b3b-88c6-b7dc9c165f7e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX3
OctisalateACTIVE INGREDIENT4X49Y0596W3
OctocryleneACTIVE INGREDIENT5A68WGF6WM3
AvobenzoneACTIVE MOIETYG63QQF2NOX3
OctisalateACTIVE MOIETY4X49Y0596W3
OctocryleneACTIVE MOIETY5A68WGF6WM3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-50249967-502-01, 49967-502-02, 49967-502-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc02c51b56-e39a-4b3b-88c6-b7dc9c165f7e2023-12-30WarningsExact identifier
ndc (package): 49967-502-02
ndc (package): 49967-502-01
ndc (package): 49967-502-03
ndc (product): 49967-502
ndc11 (package): 49967050201
ndc11 (package): 49967050202
ndc11 (package): 49967050203
spl id: 801a726b-77b7-4658-b15d-d95648ac4085
spl set id: 02c51b56-e39a-4b3b-88c6-b7dc9c165f7e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.