GARNIER OMBRELLE SPF 50 KIDS WATER RESISTANT- titanium dioxide, octisalate, drometrizole trisiloxane, avobenzone, octocrylene and ecamsule lotion 
L'Oreal USA Products Inc

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Drug Facts

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

image of a label

GARNIER OMBRELLE SPF 50 KIDS WATER RESISTANT 
titanium dioxide, octisalate, drometrizole trisiloxane, avobenzone, octocrylene and ecamsule lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-469
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE58.5 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE45 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE25 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-469-01120 in 1 CARTON07/28/2015
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-469-02240 in 1 CARTON07/28/2015
2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only07/28/2015
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.624244349manufacture(49967-469) , pack(49967-469)

Revised: 1/2020
Document Id: f2bddfa0-0179-45c5-a3ea-7a1f6a459785
Set id: f8b7a010-b794-4338-809c-7cf6fd047767
Version: 2
Effective Time: 20200117
 
L'Oreal USA Products Inc