GARNIER OMBRELLE SPF 60 COMPLETE LIGHTWEIGHT- homosalate, octocrylene, octisalate, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Homosalate 10%

Octocrylene 7%

Octisalate 5%

Avobenzone 4%

Drometrizole Trisiloxane 2.5%

Terephthalylidene Dicamphor Sulfonic Acid 0.5%

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 out of eyes. 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.

Directions

Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. For use on children less than 6 months of age, consult a health care practitioner.

Others

Aqua, Glycerin, Alcohol Denat., Styrene/Acrylates Copolymer, Dimethicone, Propylene Glycol, PEG-100 Stearate, Glyceryl Stearate, Silica, Synthetic Wax, Phenoxyethanol, Sodium Polyacrylate, Triethanolamine, Stearic Acid, Caprylyl Glycol, Palmitic Acid, PEG-8 Laurate, Xanthan Gum, Tocopherol, Disodium EDTA

image of a label

GARNIER OMBRELLE SPF 60 COMPLETE LIGHTWEIGHT 
homosalate, octocrylene, octisalate, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49967-081
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 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) AVOBENZONE40 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (AVOBENZONE - UNII:G63QQF2NOX) DROMETRIZOLE TRISILOXANE25 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PALMITIC ACID (UNII: 2V16EO95H1)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-081-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
2NDC:49967-081-02300 mL in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
3NDC:49967-081-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
4NDC:49967-081-04200 mL in 1 PACKAGE; Type 0: Not a Combination Product12/16/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only12/16/2014
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, INC.624244349manufacture(49967-081) , pack(49967-081)

Revised: 6/2021
Document Id: 01b7992e-4e36-4052-83f8-4bd565533d75
Set id: f5143c8d-25a2-43a6-9c08-4d1a43ebd44c
Version: 3
Effective Time: 20210610
 
L'Oreal USA Products Inc