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

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Drug Facts

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.

image of a label

image of a label
GARNIER OMBRELLE KIDS WET N PROTECT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY 
homosalate, octocrylene, oxybenzone, octisalate, avobenzone and drometrizole trisiloxane lotion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49967-083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE107 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE39 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE32 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
caprylyl glycol (UNII: 00YIU5438U)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-083-011 in 1 CARTON02/19/2020
190 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-083-021 in 1 CARTON02/19/2020
2200 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only02/19/2020
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA PRODUCTS, INC.624244349manufacture(49967-083) , pack(49967-083)

Revised: 12/2023
Document Id: 51becd60-305f-4bbb-a10f-03ed47becaba
Set id: eae9dcef-e6e1-4d3c-8c8c-53aea3b96344
Version: 3
Effective Time: 20231231
 
L'Oreal USA Products Inc