GARNIER OMBRELLE SPF 60 COMPLETE UVA UVB SENSITIVE ADVANCED SUNSCREEN FOR SENSITIVE SKIN HYPOALLERGENIC NON COMEDOGENIC QUICK ABSORPTION WATER/SWEAT RESISTANT 80 MINUTES- homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion 
L'Oreal USA Products Inc

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Drug facts

Active ingredients

Homosalate 15%
Octocrylene 7%
Octisalate 5%
Avobenzone 3%
Drometrizole Trisiloxane 0.5%

Other

Aqua, Silica, Styrene/acrylates Copolymer, Butyloctyl Salicylate, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Nylon-12, PEG-100 Stearate, Glyceryl Stearate, Perlite, Cara Alba, Ammonium Polyacryloylmethyl Taurate, p-Anisic Acid, Behenyl Alcohol, Chlorphenesin, Disodium EDTA, PEG-8 Laurate, Phenoxyethanol, Sodium Stearoyl Glutamate, t-Butyl Alcohol, Tocopherol, Xanthan Gum

Technology

Ombrelle’s patented filtering system with Mexoryl technology and other sunscreen filters provides effective broad-spectrum UVA/UVB protection.

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.


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 measures including: limiting time in the sun, especially from 10 a.m. – 2 p.m., and wearing long-sleeved shirts, pants, hats, and sunglasses.

Caution

For external use only. Do not use on damaged or broken skin. If rash occurs, discontinue use and consult a health care practitioner. Keep product out of eyes. IF contact occurs, rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

image of a label

GARNIER OMBRELLE SPF 60 COMPLETE UVA UVB SENSITIVE ADVANCED SUNSCREEN FOR SENSITIVE SKIN HYPOALLERGENIC NON COMEDOGENIC QUICK ABSORPTION WATER/SWEAT RESISTANT 80 MINUTES 
homosalate, octocrylene, octisalate, avobenzone and drometrizole trisiloxane lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-766
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) homosalate150 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) (AVOBENZONE - UNII:G63QQF2NOX) DROMETRIZOLE TRISILOXANE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
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)  
PERLITE (UNII: 0SG101ZGK9)  
WHITE WAX (UNII: 7G1J5DA97F)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
DOCOSANOL (UNII: 9G1OE216XY)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-766-011 in 1 CARTON01/19/2019
1200 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-766-021 in 1 CARTON01/19/2019
290 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:49967-766-036 mL in 1 PACKET; Type 0: Not a Combination Product01/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only01/19/2019
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA PRODUCTS, INC.624244349manufacture(49967-766)

Revised: 12/2023
Document Id: ed2663ee-7491-410f-8846-d585cfb335b0
Set id: f48f2c1f-f36e-4dd4-81c3-23940c993975
Version: 5
Effective Time: 20231231
 
L'Oreal USA Products Inc