GARNIER OMBRELLE SPORT ENDURANCE 60- avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion 
L'OREAL USA PRODUCTS INC

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Drug Facts

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

image of a label

image of a label
GARNIER OMBRELLE SPORT ENDURANCE 60 
avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-488
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE107.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE32.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE38.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-488-01231 mL in 1 TUBE; Type 0: Not a Combination Product02/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only02/22/2016
Labeler - L'OREAL USA PRODUCTS INC (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA, INC624244349manufacture(49967-488) , pack(49967-488)

Revised: 12/2023
Document Id: 683ad086-0f98-4671-a69e-baf17b75c779
Set id: 83d2c651-6b93-4e08-85f5-726a6d6d5477
Version: 2
Effective Time: 20231231
 
L'OREAL USA PRODUCTS INC