GARNIER OMBRELLE SPF 60 FACE ULTRA LIGHT- octocrylene, titanium dioxide, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion 
L'Oreal USA Products Inc

----------

Drug Facts

Active ingredients

Octocrylene 10%

Titanium Dioxide 4.15%

Avobenzone 3.5%

Drometrizole Trisiloxane 3%

Terephthalylidene Dicamphor Sulfonic Acid 3%

Caution

For external use only. Discontinue use if skin irratation develops or increases. If irritation persists, consult a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Before use on children under 6 months, consult a doctor. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

Directions

Apply generously 15 to 30 minutes before sun exposure. Reapply at least every 2 hours or after swimming, washing, towel drying or perspiring heavily.

Others

Aqua, Propylene Glycol, Glycerin, Cyclopentasiloxane, Triethanolamine, Isopropyl Palmitate, Stearic Acid, VP/Eicosene Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aluminum Hydroxide, Carbomer, Disodium EDTA, Glyceryl Stearate, Glycine Soja, Hydroxypropyl Methylcellulose, Methylparaben, PEG-100 Stearate, Phenoxyethanol, Propylparaben, Stearyl alcohol, Tocopherol

image of a label

GARNIER OMBRELLE SPF 60 FACE ULTRA LIGHT 
octocrylene, titanium dioxide, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-813
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE41.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE35 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE30 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SOYBEAN OIL (UNII: 241ATL177A)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-813-0175 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2011
2NDC:49967-813-026 mL in 1 TUBE; Type 0: Not a Combination Product10/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only10/10/2011
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA, INC624244349manufacture(49967-813)

Revised: 1/2020
Document Id: 2dee14e8-370a-44ca-93f6-39e142da2166
Set id: 75e1d81b-4667-4520-b8a6-0354b10b85fe
Version: 2
Effective Time: 20200117
 
L'Oreal USA Products Inc