GARNIER OMBRELLE COMPLETE SENSITIVE ADVANCED LIGHTWEIGHT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY- homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion 
L'Oreal USA Products Inc

----------

Drug Facts

Active ingredients

Homosalate 12%

Octocrylene 7%

Octisalate 5%

Avobenzone 3%

Drometrizole Trisiloxane 0.5%

Inactive ingredients

aqua, propanediol, silica, styrene/acrylates copolymer, butyloctyl salicylate, dicaprylyl carbonate, methyl methacrylate copolymer, nylon-12, PEG-100 stearate, glyceryl stearate, caprylic/capric triglyceride, pentaerythrityl tetrathylhexanoate, perlite, cera alba, p-anisic acid, t-butyl alcohol, tocopherol, sodium stearoyl glutamate, phenoxyethanol, PEG-8 laurate, behenyl alcohol, chlorphenesin, ammonium polyacryloyldimethyl taurate, xanthan gum, disodium EDTA

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly 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 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.

image of a label

image of a label
GARNIER OMBRELLE COMPLETE SENSITIVE ADVANCED LIGHTWEIGHT HYPOALLERGENIC SPF 45 MEXORYL TECHNOLOGY 
homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-397
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE120 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
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
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
NYLON-12 (UNII: 446U8J075B)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
PERLITE (UNII: 0SG101ZGK9)  
WHITE WAX (UNII: 7G1J5DA97F)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
DOCOSANOL (UNII: 9G1OE216XY)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-397-011 in 1 CARTON02/05/2020
190 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-397-021 in 1 CARTON02/05/2020
2200 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only02/05/2020
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA PRODUCTS, INC.624244349manufacture(49967-397) , pack(49967-397)

Revised: 12/2023
Document Id: f3efedca-0af9-448e-9000-42a84aca4c9a
Set id: f34fcf82-9b85-4ff8-8e80-fa92f9c5a606
Version: 3
Effective Time: 20231231
 
L'Oreal USA Products Inc