![GARNIER OMBRELLE SPF 50 KIDS WATER RESISTANT (TITANIUM DIOXIDE, OCTISALATE, DROMETRIZOLE TRISILOXANE, AVOBENZONE, OCTOCRYLENE AND ECAMSULE) LOTION [L'OREAL USA PRODUCTS INC]](https://medic.hrt.org//dailymed/images/f8b7a010-b794-4338-809c-7cf6fd047767/Ombrelle SPF 50 Kids Water Resistant Lotion.jpg)
| NDC | 49967-469-01, 49967-469-02 |
| Set ID | f8b7a010-b794-4338-809c-7cf6fd047767 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | L'Oreal USA Products Inc |
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| Product Class | |
| Product Number | |
| Application Number |
- Active ingredients
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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
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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
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE SPF 50 KIDS WATER RESISTANT
titanium dioxide, octisalate, drometrizole trisiloxane, avobenzone, octocrylene and ecamsule lotionProduct 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)
