FDA.reportPublic FDA data

Garnier Ombrelle SPF 45 Face Ultra Light

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA, INC
Effective date
2022-01-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:17:04

Label at a glance#

ProductGarnier Ombrelle SPF 45 Face Ultra Light
Active ingredientOCTOCRYLENE, DROMETRIZOLE TRISILOXANE, TITANIUM DIOXIDE, AVOBENZONE, ECAMSULE
Label structure5 sections

Dosage and administration

Apply generously 15 to 30 minutes before sun exposure. Reapply at least every 2 hours or after swimming, washing, towel drying or perspiring heavily.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 5%

Drometrizole Trisiloxane 4%

Titanium Dioxide 3.3%

Avobenzone 3%

Terephthalylidene Dicamphor Sulfonic Acid 1.5%

Caution

WARNINGS SECTION

For external use only. Discontinue use if skin irratation develops or increases. If irritation persists, consult a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Before use on children under 6 months, consult a doctor. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously 15 to 30 minutes before sun exposure. Reapply at least every 2 hours or after swimming, washing, towel drying or perspiring heavily.

Others

INACTIVE INGREDIENT SECTION

Aqua, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Glycerin, Pentylene Glycol, Stearic Acid, Triethanolamine, Potassium Cetyl Phosphate, Propylene Glycol, Panthenol, PEG-100 Stearate, Glyceryl Stearate, Phenoxyethanol, Cetyl Alcohol, Dimethicone, Methylparaben, Aluminum Hydroxide, Capryly Glycol, Ethylparaben, Carbomer, Tocopherol, Xanthan Gum, Disodium EDTA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-17949967-179-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
DROMETRIZOLE TRISILOXANEHC22845I1XACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
AVOBENZONEG63QQF2NOXACTIB
ECAMSULEM94R1PM439ACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PANTHENOLWV9CM0O67ZIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
METHYLPARABENA2I8C7HI9TIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLPARABEN14255EXE39IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
TOCOPHEROLR0ZB2556P8IACT
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
203cd2dc-4ee3-4337-98fd-c06b31f2d16f4e4b96ed-a88b-429f-9bc0-ac908725554c2023-01-29WarningsExact identifier
spl set id: 4e4b96ed-a88b-429f-9bc0-ac908725554c

Reported adverse events (FAERS/openFDA)#

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