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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2024-01-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:12:01

Label at a glance#

ProductGarnier Ombrelle SPF 30 UVA UVB Kids Wet N Protect Sunscreen Protection Even on Wet Skin Hypoallergenic Water/sweat r...
Active ingredientHOMOSALATE, octocrylene, OXYBENZONE, OCTISALATE, AVOBENZONE, DROMETRIZOLE TRISILOXANE
Label structure6 sections

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 8%
Octocrylene 4.5%
Oxybenzone 2.9%
Octisalate 2.4%
Avobenzone 2.2%
Drometrizole Trisiloxane 0.5%

Others

INACTIVE INGREDIENT SECTION

Aqua, Alcohol Denat., Dimethicone, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Caprylyl Glycol, Sodium Polyacrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Disodium EDTA

Technology

INDICATIONS & USAGE SECTION

Ombrelle’s patented filtering system with Mexoryl technology and other sunscreen filters provides effective broad-spectrum UVA/UVB protection and helps prevent sunburns.

Direction

DOSAGE & ADMINISTRATION SECTION

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. For use on children less than 6 months of age, consult a health care practitioner.

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: limiting time in the sun, especially from 10 a.m. – 2 p.m., and wearing long-sleeved shirts, pants, hats, and sunglasses.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-71149967-711-01, 49967-711-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
octocrylene5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
DROMETRIZOLE TRISILOXANEHC22845I1XACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TOCOPHEROLR0ZB2556P8IACT
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
03f86118-3a93-4d00-9810-61146e1c3cb34033ce0f-c955-47a2-b0f9-4663e43f12be2024-01-31WarningsExact identifier
spl id: 03f86118-3a93-4d00-9810-61146e1c3cb3
spl set id: 4033ce0f-c955-47a2-b0f9-4663e43f12be

Reported adverse events (FAERS/openFDA)#

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