![GARNIER OMBRELLE SPF 30 FACE ULTRA LIGHT (OCTOCRYLENE, DROMETRIZOLE TRISILOXANE, AVOBENZONE, TITANIUM DIOXIDE AND TEREPHTHALYLIDENE DICAMPHOR SULFONIC ACID) CREAM [L'OREAL USA PRODUCTS INC]](https://medic.hrt.org//dailymed/images/d4a0649c-fabb-4282-874b-58acef8f7f7a/Ombrelle Face Cream SPF 30.jpg)
| NDC | 49967-162-01 |
| Set ID | d4a0649c-fabb-4282-874b-58acef8f7f7a |
| Category | HUMAN OTC DRUG LABEL |
| Packager | L'Oreal USA Products Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active ingredients
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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
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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
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE SPF 30 FACE ULTRA LIGHT
octocrylene, drometrizole trisiloxane, avobenzone, titanium dioxide and terephthalylidene dicamphor sulfonic acid creamProduct 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)
