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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:21:31

Label at a glance#

ProductGarnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, DROMETRIZOLE TRISILOXANE
Label structure9 sections

Dosage and administration

Adults and children 6 months and up. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 80 minutes of swimming or sweating and immediately after towel drying.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 12%

Octocrylene 7%

Octisalate 5%

Avobenzone 3%

Drometrizole Trisiloxane 0.5%

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqua, propanediol, silica, styrene/acrylates copolymer, butyloctyl salicylate, dicaprylyl carbonate, methyl methacrylate copolymer, nylon-12, PEG-100 stearate, glyceryl stearate, caprylic/capric triglyceride, pentaerythrityl tetrathylhexanoate, perlite, cera alba, p-anisic acid, t-butyl alcohol, tocopherol, sodium stearoyl glutamate, phenoxyethanol, PEG-8 laurate, behenyl alcohol, chlorphenesin, ammonium polyacryloyldimethyl taurate, xanthan gum, disodium EDTA

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

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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

Adults and children 6 months and up. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 80 minutes of swimming or sweating and immediately after towel drying.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

90 mL90 mL

image of a labelimage of a label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-397-01Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology1 in 1 CARTONLOTION14
49967-397-01Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology90 mL in 1 TUBELOTION904
49967-397-02Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology1 in 1 CARTONLOTION14
49967-397-02Garnier Ombrelle Complete Sensitive Advanced Lightweight hypoallergenic SPF 45 Mexoryl Technology200 mL in 1 TUBELOTION2004

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-39749967-397-01, 49967-397-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
DROMETRIZOLE TRISILOXANEHC22845I1XACTIB
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
NYLON-12446U8J075BIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PENTAERYTHRITYL TETRAETHYLHEXANOATEXJ7052W897IACT
PERLITE0SG101ZGK9IACT
WHITE WAX7G1J5DA97FIACT
P-ANISIC ACID4SB6Y7DMM3IACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-8 LAURATE762O8IWA10IACT
DOCOSANOL9G1OE216XYIACT
CHLORPHENESINI670DAL4SZIACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)F01RIY4371IACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM7FLD91C86KIACT

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
55628f43-2175-4877-8a2c-3b59e812ddccf34fcf82-9b85-4ff8-8e80-fa92f9c5a6062025-12-09WarningsExact identifier
spl id: 55628f43-2175-4877-8a2c-3b59e812ddcc
spl set id: f34fcf82-9b85-4ff8-8e80-fa92f9c5a606

Reported adverse events (FAERS/openFDA)#

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