Label: GARNIER OMBRELLE SPORT ENDURANCE 60- avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotion
- NDC Code(s): 49967-488-01
- 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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- Active ingredients
- Warnings
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Directions
Adults and children over 6 months and up. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours, after 80 minutes of swimming or sweating and immediately after towel drying. Can be applied on dry or wet skin. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measure including limit time in the sun 11 a.m - 3 p.m and wear long sleeve shirts, pants, hats and sunglasses.
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE SPORT ENDURANCE 60
avobenzone, drometrizole trisiloxane, homosalate, octisalate, octocrylene and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-488 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE 5 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 107.2 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 32.1 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 38.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ALCOHOL (UNII: 3K9958V90M) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-8 LAURATE (UNII: 762O8IWA10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-488-01 231 mL in 1 TUBE; Type 0: Not a Combination Product 02/22/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date export only 02/22/2016 Labeler - L'OREAL USA PRODUCTS INC (002136794) Establishment Name Address ID/FEI Business Operations L'OREAL USA, INC 624244349 manufacture(49967-488) , pack(49967-488)