GARNIER OMBRELLE ULTRA LIGHT HYDRATING FACE SUNSCREEN- avobenzone, drometrizole trisiloxane, octocrylene and titanium dioxide lotion

Garnier Ombrelle Ultra Light Hydrating Face Sunscreen by

Drug Labeling and Warnings

Garnier Ombrelle Ultra Light Hydrating Face Sunscreen 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

Avobenzone 3.5%
Octocrylene 10%
Drometrizole Trisiloxane 3%
Titanium Dioxide 4.15%

Warnings

For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughlly with water. Do not use on broken skin. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away. 

Directions 

Adults and children over 6 months and up. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, use a water resistant sunscreen if swimming or sweating.

Inactive ingredients

water, propylene glycol, glycerin, cyclopentasiloxane, triethanolamine, isoproypl palmitate, stearic acid, VP/eicosene copolymer, dimethicone, acrylates/c10-30 alkyl acrylate crosspolyer, aluminum hydroxide, carbomer, disodium EDTA, glyceryl stearate, glycine soja, hydroxypropyl methylcellulose, methylparaben, PEG-100 stearate, phenoxyethanol, propylparaben, stearyl alcohol, tocopherol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE ULTRA LIGHT HYDRATING FACE SUNSCREEN 
avobenzone, drometrizole trisiloxane, octocrylene and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	35 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	41.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
STEARIC ACID (UNII: 4ELV7Z65AP)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SOYBEAN (UNII: L7HT8F1ZOD)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-200-01	1 in 1 CARTON	03/01/2007
1		75 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		03/01/2007

Labeler - L'OREAL USA PRODUCTS INC (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC		624244349	manufacture(49967-200) , pack(49967-200)