GARNIER OMBRELLE SPF 30 KIDS WATER RESISTANT- oxybenzone, octisalate, octocrylene, titanium dioxide, avobenzone and terephthalylidene dicamphor sulfonic acid lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Oxybenzone 5%

Octisalate 5%

Octocrylene 3.5%

Titanium Dioxide 3.3%

Avobenzone 3%

Terephthalylidene Dicamphor Sulfonic Acid 1%

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 Center right away.

Directions

Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 40 minutes of swimming or sweating and immediately after towel drying. For use of children less than 6 months of age, consult a health care practitioner.

Others

Aqua, Glycerin, Dicaprylyl Carbonate, Propylene Glycol, Alcohol Denat., Hydrogenated Polyisobutene, Triethanolanime, VP/Eicosene Copolymer, Dimethicone, Isohexadecane, Panthenol, Stearic Acid, Phenoxyethanol, PEG-100 Stearate, Glyceryl Stearate, Aluminum Hydroxide, Methylparaben, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Disodium EDTA, Xanthan Gum, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben

image of a label

GARNIER OMBRELLE SPF 30 KIDS WATER RESISTANT 
oxybenzone, octisalate, octocrylene, titanium dioxide, avobenzone and terephthalylidene dicamphor sulfonic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-462
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE35 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE33 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
TROLAMINE (UNII: 9O3K93S3TK)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PANTHENOL (UNII: WV9CM0O67Z)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-462-011 in 1 CARTON10/12/2011
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-462-021 in 1 CARTON10/12/2011
2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only10/12/2011
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.624244349manufacture(49967-462) , pack(49967-462)

Revised: 1/2020
Document Id: b07d7216-5ba9-4e4d-948e-4e958145b9f7
Set id: a6620063-a357-4b2f-97e5-f0b18930a1ac
Version: 2
Effective Time: 20200117
 
L'Oreal USA Products Inc