GARNIER OMBRELLE SPF 30 SPORT ENDURANCE WATER RESISTANT- avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion

Garnier Ombrelle SPF 30 Sport Endurance Water Resistant by

Drug Labeling and Warnings

Garnier Ombrelle SPF 30 Sport Endurance Water Resistant by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 2.24%

Drometrizole Trisiloxane 0.5%

Homosalate 8%

Octisalate 2.4%

Octocrylene 4.48%

Oxybenzone 2.88%

Warnings

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 Center right away.

Directions

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. For use on children less than 6 months of age, consult a health care practitioner.

Inactive ingredients

water, alcohol denat., dimethicone, cyclopentsailoxane, tocopherol, sodium polyacrylate, phenoxyethanol, silica, menthyl lactate, caprylyl glycol, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE SPF 30 SPORT ENDURANCE WATER RESISTANT 
avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-747
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	22.4 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	24 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	44.8 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	28.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
METHYL LACTATE, (-)- (UNII: 0379G9C44S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-747-01	231 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		01/01/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC.		624244349	manufacture(49967-747) , pack(49967-747)