GARNIER OMBRELLE KIDS WET N PROTECT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY- homosalate, octocrylene, oxybenzone, octisalate, avobenzone and drometrizole trisiloxane lotion

Garnier Ombrelle Kids Wet N Protect Hypoallergenic SPF 45 Mexoryl Technology by

Drug Labeling and Warnings

Garnier Ombrelle Kids Wet N Protect Hypoallergenic SPF 45 Mexoryl Technology by is a Prescription medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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)	NDC: 49967-083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	107 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	39 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	32 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-083-01	1 in 1 CARTON	02/19/2020
1		90 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-083-02	1 in 1 CARTON	02/19/2020
2		200 mL in 1 TUBE; Type 0: Not a Combination Product

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	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(49967-083) , pack(49967-083)