GARNIER OMBRELLE SPF 30 SPORT ENDURANCE WATER RESISTANT- avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion 
L'Oreal USA Products Inc

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Drug Facts

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

image of a label

image of a label
GARNIER OMBRELLE SPF 30 SPORT ENDURANCE WATER RESISTANT 
avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-747
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE22.4 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE24 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE44.8 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE28.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-747-01231 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2017
2NDC:49967-747-0250 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only01/01/2017
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA, INC.624244349manufacture(49967-747)

Revised: 12/2023
Document Id: 83b49c8a-c97f-4e3d-ad7b-137228d58701
Set id: 77f3fb89-d2b3-4932-b034-92b64d726426
Version: 9
Effective Time: 20231231
 
L'Oreal USA Products Inc