GARNIER OMBRELLE CLEAR SPORT 50 PLUS WATER RESISTANT 40 MINUTES- avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene spray

Garnier Ombrelle Clear Sport 50 Plus Water Resistant 40 Minutes by

Drug Labeling and Warnings

Garnier Ombrelle Clear Sport 50 Plus Water Resistant 40 Minutes 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 5%

Drometrizole trisiloxane 2%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Warnings

For external use only. Flammability Warning. Do not use in presence of open flame or spark. When using this product avoid contact witheyes. If contact occurs, rinse thoroughlly with water. Do not use on broken skin. Stop use and ask a doctor if rash occurs. Other warnings. Contents under pressure, do not place in hot water or near radiator, stoves or other sources of heat, do not puncture or incinerate container or store at temperatures over 50oC. 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 of age. Shake well before use. Spray generously and spread evenly by hand 15 minutes before sun exposure. Hold container 10 to 15 cm from the skin to apply, do not spray directly onto face. Spray on hand then apply to face. Do not apply in windy conditions and use in a well ventilated area, avoid inhaling or exposing others to spray. Reapply at least every 2 hours, after 80 minutes of swimming or sweating, right after towel drying. 

Others

alcohol denat., c12-15 alkyl benzoate, ethylenediamine/stearyl dimer dilinoleate copolymer, acrylates/octylacrylamide copolymer, tocopherol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE CLEAR SPORT 50 PLUS WATER RESISTANT 40 MINUTES 
avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-739
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	50 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-739-01	122 mL in 1 CONTAINER; Type 0: Not a Combination Product	02/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		02/01/2015

Labeler - L'OREAL USA PRODUCTS INC (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		624244349	manufacture(49967-739) , pack(49967-739)