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Drug Facts

Manufacturer
L'Oreal USA Products Inc | SICOS ET CIE
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:14:09

Label at a glance#

ProductLancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Anti...
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure14 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%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

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

Flammable until dry.

SAFE HANDLING WARNING SECTION

Do not use near fire, flame, or heat.

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, alcohol denat., styrene/acrylates copolymer, dimethicone, acrylates/dimethicone copolymer, tocopherol, dicaprylyl ether, sodium polyacrylate, sodium dodecylbenzenesulfonate, sodium benzoate, diethylhexyl syringylidenemalonate, phenoxyethanol, PEG-8 laurate, trisodium ethylenediamine disuccinate, menthyl lactate, pentylene glycol, mentha piperita (peppermint) extract, xanthan gum, propanediol, leontopodium alpinum flower/leaf extract, caprylyl glycol, caprylic/capric triglyceride, acrylates/c10-30 alkyl acrylate crosspolymer, moringa oleifera seed extract, rosa meichibon/delgramaue callus, disodium phosphate, butylene glycol, citric acid, potassium sorbate, glycerin, 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

image of a cartonimage of a carton

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-614-01Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E1 in 1 CARTONCREAM18
49967-614-01Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E30 mL in 1 TUBECREAM308
49967-614-02Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E10 mL in 1 TUBECREAM108
49967-614-02Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E1 in 1 CARTONCREAM18
49967-614-03Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E1 in 1 CARTONCREAM18
49967-614-03Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E5 mL in 1 TUBECREAM58
49967-614-04Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E1 in 1 CARTONCREAM18
49967-614-04Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E1 mL in 1 TUBECREAM18
49967-614-05Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E50 mL in 1 TUBECREAM508
49967-614-05Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E1 in 1 CARTONCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-614LANCOME PARIS UV EXPERT AQUAGEL DEFENSE 50 PLUS SUNSCREEN BROAD SPECTRUM SPF 50 PLUS PRIMER AND MOISTURIZER WITH ANTIOXIDANT VITAMIN E (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) CREAM [L'OREAL USA PRODUCTS INC]8Current NDC, Legacy NDC, 10 package rows20240627_0200a00f-2b57-454d-933d-a7d48644be6e.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-61449967-614-01, 49967-614-02, 49967-614-03, 49967-614-04, 49967-614-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
DIMETHICONE92RU3N3Y1OIACT
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)S7ZA3CCJ4MIACT
TOCOPHEROLR0ZB2556P8IACT
DICAPRYLYL ETHER77JZM5516ZIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
SODIUM BENZOATEOJ245FE5EUIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-8 LAURATE762O8IWA10IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
PENTYLENE GLYCOL50C1307PZGIACT
MENTHA X PIPERITA WHOLE79M2M2UDA9IACT
XANTHAN GUMTTV12P4NEEIACT
PROPANEDIOL5965N8W85TIACT
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOPQQC1AK06RKIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
MORINGA OLEIFERA LEAF4WET1AWO9BIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

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 UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin EAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc0200a00f-2b57-454d-933d-a7d48644be6e2024-06-25WarningsExact identifier
ndc (package): 49967-614-05
ndc (package): 49967-614-03
ndc (package): 49967-614-02
ndc (package): 49967-614-04
ndc (package): 49967-614-01
ndc (product): 49967-614
ndc11 (package): 49967061403
ndc11 (package): 49967061405
ndc11 (package): 49967061401
ndc11 (package): 49967061402
ndc11 (package): 49967061404
spl id: 68dea1e6-2dc9-43cc-96f7-e10f0592a216
spl set id: 0200a00f-2b57-454d-933d-a7d48644be6e

Reported adverse events (FAERS/openFDA)#

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