FDA.reportPublic FDA data

LOreal Paris Ombrelle SPF 30 Complete Water Resistant

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA, INC.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:17:00

Label at a glance#

ProductLOreal Paris Ombrelle SPF 30 Complete Water Resistant
Active ingredientAVOBENZONE, OCTOCRYLENE, ECAMSULE, TITANIUM DIOXIDE
Label structure5 sections

Dosage and administration

Apply generously (a palmful for an adult body) 15 to 30 minutes before sun exposure. Reapply every 2 hours or as needed after swimming, washing, towel drying or perspiring heavily.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octocrylene 10%

Terephthalylidene Dicamphor Sulfonic Acid 1%

Titanium Dioxide 2.2%

Warnings

WARNINGS SECTION

For external use only. Discontinue use if irritation 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 (a palmful for an adult body) 15 to 30 minutes before sun exposure. Reapply every 2 hours or as needed after swimming, washing, towel drying or perspiring heavily.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, propylene glycol, glycerin, cyclopentasiloxane, isopropyl palmitate, stearic acid, triethanolamine, VP/eicosene copolymer, dimethicone, panthenol, phenoxyethanol, PEG-100 stearate, glyceryl stearate, methylparaben, aluminum hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, tocopherol, disodium EDTA, propylparaben, xanthan gum

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 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-00049967-000-01, 49967-000-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ECAMSULEM94R1PM439ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
DIMETHICONE92RU3N3Y1OIACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CHLORPHENESINI670DAL4SZIACT
TOCOPHEROLR0ZB2556P8IACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLPARABENZ8IX2SC1OHIACT
XANTHAN GUMTTV12P4NEEIACT

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
e1b03133-f9d3-4053-93eb-c81eecc402ba2d3c2c8b-7499-47ec-abc5-26cf6a757be02023-01-29WarningsExact identifier
spl set id: 2d3c2c8b-7499-47ec-abc5-26cf6a757be0

Reported adverse events (FAERS/openFDA)#

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