GARNIER OMBRELLE SPF 30 FACE ULTRA LIGHT- octocrylene, drometrizole trisiloxane, avobenzone, titanium dioxide and terephthalylidene dicamphor sulfonic acid cream 
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Octocrylene 5%

Drometrizole Trisiloxane 4%

Avobenzone 3%

Titanium Dioxide 2.9%

Terephthalylidene Dicamphor Sulfonic Acid 1%

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, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Glycerin, Pentylene Glycol, Stearic Acid, Triethanolamine, Potassium Cetyl Phosphate, Propylene Glycol, Panthenol, PEG-100 Stearate, Glyceryl Stearate, Phenoxyethanol, Cetyl Alcohol, Dimethicone, Methylparaben, Aluminum Hydroxide, Capryly Glycol, Ethylparaben, Carbomer, Tocopherol, Xanthan Gum, Disodium EDTA

image of tube

GARNIER OMBRELLE SPF 30 FACE ULTRA LIGHT 
octocrylene, drometrizole trisiloxane, avobenzone, titanium dioxide and terephthalylidene dicamphor sulfonic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-162
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE29 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PANTHENOL (UNII: WV9CM0O67Z)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLPARABEN (UNII: 14255EXE39)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-162-0175 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/10/2011
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA, INC624244349manufacture(49967-162)

Revised: 6/2018
Document Id: ab78ed30-8c38-4b94-818a-fefdcbdad04e
Set id: d4a0649c-fabb-4282-874b-58acef8f7f7a
Version: 1
Effective Time: 20180621
 
L'Oreal USA Products Inc