GARNIER OMBRELLE SPF 30 FACE ULTRA LIGHT- octocrylene, drometrizole trisiloxane, avobenzone, titanium dioxide and terephthalylidene dicamphor sulfonic acid cream

Garnier Ombrelle SPF 30 Face Ultra Light by

Drug Labeling and Warnings

Garnier Ombrelle SPF 30 Face Ultra Light by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE SPF 30 FACE ULTRA LIGHT 
octocrylene, drometrizole trisiloxane, avobenzone, titanium dioxide and terephthalylidene dicamphor sulfonic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	29 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-162-01	75 mL in 1 TUBE; Type 0: Not a Combination Product	10/10/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/10/2011

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		624244349	manufacture(49967-162)