GARNIER OMBRELLE SPORT VAPORISATEUR BROAD SPECTRUM SPF 30 SWEAT RESISTANT 80 MINUTES- avobenzone, octisalate, octocrylene and oxybenzone spray

Garnier Ombrelle Sport Vaporisateur Broad Spectrum SPF 30 Sweat Resistant 80 Minutes by

Drug Labeling and Warnings

Garnier Ombrelle Sport Vaporisateur Broad Spectrum SPF 30 Sweat Resistant 80 Minutes by is a Otc medication manufactured, distributed, or labeled by L'OREAL USA PRODUCTS INC, Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 10%

Oxybenzone 6%

Warnings

For external use only. Flammability Warning. Do not use in presence of open flame or spark. Do not use on broken skin. When using this product avoid contact with eyes. If contact occurs, rinse thoroughlly 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 over 6 months and up. 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 hands then apply to face. Do not apply in windy conditions. Use in a well-ventilated area. Reapply at least every 2 hours, after 80 minutes of swimming or sweating, and immediately after towel drying. 

Others

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE SPORT VAPORISATEUR BROAD SPECTRUM SPF 30 SWEAT RESISTANT 80 MINUTES 
avobenzone, octisalate, octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-772
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-772-01	145 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		01/01/2021

Labeler - L'OREAL USA PRODUCTS INC (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	manufacture(49967-772)