Label: GARNIER OMBRELLE SPF 60 FACE ULTRA LIGHT- octocrylene, titanium dioxide, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotion
- NDC Code(s): 49967-813-01, 49967-813-02, 49967-813-03
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated December 31, 2023
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- Official Label (Printer Friendly)
- 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, Propylene Glycol, Glycerin, Cyclopentasiloxane, Triethanolamine, Isopropyl Palmitate, Stearic Acid, VP/Eicosene Copolymer, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aluminum Hydroxide, Carbomer, Disodium EDTA, Glyceryl Stearate, Glycine Soja, Hydroxypropyl Methylcellulose, Methylparaben, PEG-100 Stearate, Phenoxyethanol, Propylparaben, Stearyl alcohol, Tocopherol
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE SPF 60 FACE ULTRA LIGHT
octocrylene, titanium dioxide, avobenzone, drometrizole trisiloxane and terephthalylidene dicamphor sulfonic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-813 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 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 ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TROLAMINE (UNII: 9O3K93S3TK) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) STEARIC ACID (UNII: 4ELV7Z65AP) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SOYBEAN OIL (UNII: 241ATL177A) 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) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-813-01 75 mL in 1 TUBE; Type 0: Not a Combination Product 10/10/2011 2 NDC:49967-813-02 6 mL in 1 TUBE; Type 0: Not a Combination Product 10/30/2013 3 NDC:49967-813-03 90 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 export only 10/10/2011 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'OREAL USA, INC 624244349 manufacture(49967-813)
