GARNIER OMBRELLE SPORT ENDURANCE 60- avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion

Garnier Ombrelle Sport Endurance 60 by

Drug Labeling and Warnings

Garnier Ombrelle Sport Endurance 60 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 3%

Drometrizole trisiloxane 0.5%

Homosalate 10.72%

Octisalate 3.21%

Octocrylene 6%

Oxybenzone 3.86%

Warnings

For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughlly with water. Do not use on broken skin. 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 over 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. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk  regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measure including limit time in the sun 11 a.m - 3 p.m and wear long sleeve shirts, pants, hats and sunglasses.

Inactive ingredients

water, dimethicone, alcohol denat., styrene/acrylates copolymer, acrylates/dimethicone copolymer, tocopherol, sodium polyacrylate, phenoxyethanol, PEG-8 laurate, silica, menthyl lactate, caprylyl glycol, acrylates/c10-30 alkyl acrylate crosspolymer, disodium EDTA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE SPORT ENDURANCE 60 
avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-488
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	107.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	32.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	38.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-8 LAURATE (UNII: 762O8IWA10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
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: 49967-488-01	231 mL in 1 TUBE; Type 0: Not a Combination Product	02/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		02/22/2016

Labeler - L'OREAL USA PRODUCTS INC (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		624244349	manufacture(49967-488) , pack(49967-488)