Garnier Ombrelle SPF 45 Complete Lightweight: Package Insert and Label Information

GARNIER OMBRELLE SPF 45 COMPLETE LIGHTWEIGHT- homosalate, octocrylene, octisalate, avobenzone, drometrizole trisiloxane and ecamsule lotion
L’Oreal USA Products Inc

Active ingredients

Homosalate 10%

Octocrylene 6.5%

Octisalate 5%

Avobenzone 3.5%

Drometrizole Trisiloxane 2.5%

Terephthalylidene Dicamphor Sulfonic Acid 0.5%

Caution

For external use only. Do not use on damaged or broken skin. If rash occurs, discontinue use and consult a health care practitioner. Keep out of eyes. 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

Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. For use on children less than 6 months of age, consult a health care practitioner.

Others

Aqua, Glycerin, Alcohol Denat., Styrene/Acrylates Copolymer, Dimethicone, Propylene Glycol, PEG-100 Stearate, Glyceryl Stearate, Silica, Synthetic Wax, Phenoxyethanol, Sodium Polyacrylate, Triethanolamine, Stearic Acid, Caprylyl Glycol, Palmitic Acid, PEG-8 Laurate, Xanthan Gum, Tocopherol, Disodium EDTA

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GARNIER OMBRELLE SPF 45 COMPLETE LIGHTWEIGHT
homosalate, octocrylene, octisalate, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NHRIC:49967-098
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 65 mg in 1 mL
octisalate (OCTISALATE) octisalate 50 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 35 mg in 1 mL
DROMETRIZOLE TRISILOXANE (AVOBENZONE) DROMETRIZOLE TRISILOXANE 25 mg in 1 mL
ECAMSULE (ECAMSULE) ECAMSULE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
ALCOHOL
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)
DIMETHICONE
PROPYLENE GLYCOL
PEG-100 STEARATE
GLYCERYL MONOSTEARATE
SILICON DIOXIDE
PHENOXYETHANOL
TROLAMINE
STEARIC ACID
CAPRYLYL GLYCOL
PALMITIC ACID
PEG-8 LAURATE
XANTHAN GUM
TOCOPHEROL
EDETATE DISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:49967-098-01 120 mL in 1 BOTTLE None
2 NHRIC:49967-098-02 240 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
export only 12/22/2014
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L’OREAL USA, INC. 624244349 manufacture (49967-098), pack (49967-098)

Revised: 01/2022 L’Oreal USA Products Inc

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