Garnier Ombrelle SPF 45 Kids Hypoallergenic: Package Insert and Label Information

GARNIER OMBRELLE SPF 45 KIDS HYPOALLERGENIC- oxybenzone, octisalate, titanium dioxide, octocrylene, ecamsule and avobenzone lotion
L’Oreal USA Products Inc

Active ingredients

Oxybenzone 5%

Octisalate 5%

Titanium Dioxide 4.2%

Octocrylene 3.5%

Terephthalylidene Dicamphor Sulfonic Acid 3%

Avobenzone 2%

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 product ouf 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 Center 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.

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GARNIER OMBRELLE SPF 45 KIDS HYPOALLERGENIC
oxybenzone, octisalate, titanium dioxide, octocrylene and terephthalylidene dicamphor sulfonic acid lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NHRIC:49967-493
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBENZONE (OXYBENZONE) OXYBENZONE 50 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 42 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 35 mg in 1 mL
ECAMSULE (ECAMSULE) ECAMSULE 30 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
DICAPRYLYL CARBONATE
ALCOHOL
TROLAMINE
ISOHEXADECANE
PEG-100 STEARATE
POTASSIUM CETYL PHOSPHATE
GLYCERYL MONOSTEARATE
VINYLPYRROLIDONE/EICOSENE COPOLYMER
DIMETHICONE
PANTHENOL
STEARIC ACID
PHENOXYETHANOL
STEARYL ALCOHOL
ALUMINUM HYDROXIDE
METHYLPARABEN
TOCOPHEROL
EDETATE DISODIUM
XANTHAN GUM
BUTYLPARABEN
ETHYLPARABEN
POLYSORBATE 80
ISOBUTYLPARABEN
PROPYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:49967-493-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 120 mL in 1 BOTTLE This package is contained within the CARTON (49967-493-01)
2 NHRIC:49967-493-02 1 BOTTLE in 1 CARTON contains a BOTTLE
2 240 mL in 1 BOTTLE This package is contained within the CARTON (49967-493-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
export only 09/24/2011
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, Inc. 624244349 manufacture (49967-493), pack (49967-493)

Revised: 01/2022 L’Oreal USA Products Inc

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