FDA.reportPublic FDA data

Garnier Ombrelle SPF 50 Kids Water Resistant

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:17:48

Label at a glance#

ProductGarnier Ombrelle SPF 50 Kids Water Resistant
Active ingredientTITANIUM DIOXIDE, Octisalate, DROMETRIZOLE TRISILOXANE, AVOBENZONE, OCTOCRYLENE, ECAMSULE
Label structure5 sections

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 40 minutes of swimming or sweating and immediately after towel drying. For use on children less than 6 months of age, consult a health care practitioner.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5.85%

Octisalate 5%

Drometrizole Trisiloxane 4.5%

Avobenzone 3%

Octocrylene 2.5%

Ecamsule 1.5%

Caution

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. If rash occurs,discontinue use and consult a health care practitioner. Keep product out of eyes. If contact occurs, rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 40 minutes of swimming or sweating and immediately after towel drying. For use on children less than 6 months of age, consult a health care practitioner.

Others

INACTIVE INGREDIENT SECTION

Aqua, C12-15 Alkyl Benzoate, Alcohol Denat., Caprylic/Capric Triglyceride, Isododecane, Propylene Glycol, Dimethicone, Glycerin, PEG-30 Dipolyhydroxystearate, Lauryl PEG/PPG-18/18 Methicone, Synthetic Wax, Ammonium Polyacryloyldimethyl Taurate, Silica, Triethanolamine, Cellulose Gum, Caprylyl Glycol, Dimethicone Crosspolymer, Isostearyl Alcohol, Dedecene, Poloxamer 407, Glycine Soja Oil, Tocopherol, Pentasodium Ethylenediamine Tetramethylene Phosphonate, Hydrolyzed Algin, Magnesium Sulfate, Manganese Sulfate, Benzyl Benzoate, Benzyl Alcohol

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 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-46949967-469-01, 49967-469-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
Octisalate4X49Y0596WACTIB
DROMETRIZOLE TRISILOXANEHC22845I1XACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ECAMSULEM94R1PM439ACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALCOHOL3K9958V90MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ISODODECANEA8289P68Y2IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TROLAMINE9O3K93S3TKIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
DODECENEWYE669F3GRIACT
POLOXAMER 407TUF2IVW3M2IACT
SOYBEAN OIL241ATL177AIACT
TOCOPHEROLR0ZB2556P8IACT
LEXIDRONAM PENTASODIUM2ZYX2V82ADIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
MANGANESE SULFATEW00LYS4T26IACT
BENZYL BENZOATEN863NB338GIACT
BENZYL ALCOHOLLKG8494WBHIACT

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
f0dff3e4-2e13-4dcf-b3d7-9c620f4f5c45f8b7a010-b794-4338-809c-7cf6fd0477672023-01-29WarningsExact identifier
spl set id: f8b7a010-b794-4338-809c-7cf6fd047767

Reported adverse events (FAERS/openFDA)#

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