Garnier Ombrelle Kids Wet N Protect Hypoallergenic SPF 45 Mexoryl Technology: Package Insert and Label Information

GARNIER OMBRELLE KIDS WET N PROTECT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY- homosalate, octocrylene, oxybenzone, octisalate, avobenzone and drometrizole trisiloxane lotion
L’Oreal USA Products Inc

Active ingredients

Homosalate 10.7%
Octocrylene 6%
Oxybenzone 3.9%
Octisalate 3.2%
Avobenzone 3%
Drometrizole Trisiloxane 0.5%

Inactive ingredients

Aqua, Dimethicone, Alcohol Denat., Styrene/Acrylates Copolymer, Acrylates/Dimethicone Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Disodium EDTA, PEG-8 Laurate, Phenoxyethanol, Sodium Dodecylbenzenesulfonate, Sodium Polyacrylate, Tocopherol

Use:

Helps prevent sunburn.

Warnings

For external use only.

Do not use

on broken skin

When using this product,

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children 6 months and up. 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. Can be applied on dry or wet skin.

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GARNIER OMBRELLE KIDS WET N PROTECT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY
homosalate, octocrylene, oxybenzone, octisalate, avobenzone and drometrizole trisiloxane lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NHRIC:49967-083
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 107 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 60 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 39 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 32 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
DROMETRIZOLE TRISILOXANE (DROMETRIZOLE TRISILOXANE) DROMETRIZOLE TRISILOXANE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
ALCOHOL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
caprylyl glycol
EDETATE SODIUM
PEG-8 LAURATE
PHENOXYETHANOL
SODIUM DODECYLBENZENESULFONATE
SODIUM POLYACRYLATE (2500000 MW)
TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:49967-083-01 1 TUBE in 1 CARTON contains a TUBE
1 90 mL in 1 TUBE This package is contained within the CARTON (49967-083-01)
2 NHRIC:49967-083-02 1 TUBE in 1 CARTON contains a TUBE
2 200 mL in 1 TUBE This package is contained within the CARTON (49967-083-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
export only 02/19/2020
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L’OREAL USA PRODUCTS, INC. 624244349 manufacture (49967-083), pack (49967-083)

Revised: 01/2022 L’Oreal USA Products Inc

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