GARNIER OMBRELLE SPF 50 KIDS WATER RESISTANT- titanium dioxide, octisalate, drometrizole trisiloxane, avobenzone, octocrylene and ecamsule lotion

Garnier Ombrelle SPF 50 Kids Water Resistant by

Drug Labeling and Warnings

Garnier Ombrelle SPF 50 Kids Water Resistant 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

Titanium Dioxide 5.85%

Octisalate 5%

Drometrizole Trisiloxane 4.5%

Avobenzone 3%

Octocrylene 2.5%

Ecamsule 1.5%

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 product out of eyes. If contact occurs, 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, after 40 minutes of swimming or sweating and immediately after towel drying. For use on children less than 6 months of age, consult a health care practitioner.

Others

Aqua, C12-15 Alkyl Benzoate, Alcohol Denat., Caprylic/Capric Triglyceride, Isododecane, Propylene Glycol, Dimethicone, Glycerin, PEG-30 Dipolyhydroxystearate, Lauryl PEG/PPG-18/18 Methicone, Synthetic Wax, Ammonium Polyacryloyldimethyl Taurate, Silica, Triethanolamine, Cellulose Gum, Caprylyl Glycol, Dimethicone Crosspolymer, Isostearyl Alcohol, Dedecene, Poloxamer 407, Glycine Soja Oil, Tocopherol, Pentasodium Ethylenediamine Tetramethylene Phosphonate, Hydrolyzed Algin, Magnesium Sulfate, Manganese Sulfate, Benzyl Benzoate, Benzyl Alcohol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GARNIER OMBRELLE SPF 50 KIDS WATER RESISTANT 
titanium dioxide, octisalate, drometrizole trisiloxane, avobenzone, octocrylene and ecamsule lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-469
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	58.5 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X)	DROMETRIZOLE TRISILOXANE	45 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALCOHOL (UNII: 3K9958V90M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISODODECANE (UNII: A8289P68Y2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DODECENE (UNII: WYE669F3GR)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
LEXIDRONAM PENTASODIUM (UNII: 2ZYX2V82AD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MANGANESE SULFATE (UNII: W00LYS4T26)
BENZYL BENZOATE (UNII: N863NB338G)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-469-01	120 in 1 CARTON	07/28/2015
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-469-02	240 in 1 CARTON	07/28/2015
2		240 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		07/28/2015

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		624244349	manufacture(49967-469) , pack(49967-469)