GARNIER OMBRELLE KIDS ULTRA GENTLE SPF 50 PLUS WATER RESISTANT 80 MINUTES- avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene spray 
L'OREAL USA PRODUCTS INC

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Drug Facts

Active ingredients

Avobenzone 3%

Drometrizole trisiloxane 0.5%

Homosalate 15%

Octisalate 5%

Octocrylene 3%

Warnings

For external use only. Flammability Warning. Do not use in presence of open flame or spark. When using this product avoid contact witheyes. If contact occurs, rinse thoroughlly with water. Do not use on broken skin. Stop use and ask a doctor if rash occurs. Other warnings. Contents under pressure, do not place in hot water or near radiator, stoves or other sources of heat, do not puncture or incinerate container or store at temperatures over 50oC. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away. 

Directions 

Adults and children over 6 months of age. Shake well before use. Spray generously and spread evenly by hand 15 minutes before sun exposure. Hold container 10 to 15 cm from the skin to apply, do not spray directly onto face. Spray on hand then apply to face. Do not apply in windy conditions and use in a well ventilated area, avoid inhaling or exposing others to spray. Reapply at least every 2 hours, after 80 minutes of swimming or sweating, right after towel drying. 

Others

water, dimethicone, glycerin, butyloctyl salicylate, styrene/acrylates copolymer, isopropyl lauroyl sarcosinate, sorbitan tristearate, isotridecyl isononanoate, polyurethane-35, caprylyl methicone, phenoxyethanol, caprylyl glycol, sodium stearoyl glutamate, polysorbate 61, glyceryl stearate, PEG-8 laurate, dimethiconol, PEG-12 dimethicone, p-anisic acid, stearyl alcohol, tocopherol, disodium EDTA

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GARNIER OMBRELLE KIDS ULTRA GENTLE SPF 50 PLUS WATER RESISTANT 80 MINUTES 
avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-520
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
DROMETRIZOLE TRISILOXANE (UNII: HC22845I1X) (DROMETRIZOLE TRISILOXANE - UNII:HC22845I1X) DROMETRIZOLE TRISILOXANE5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)  
SORBITAN TRISTEARATE (UNII: 6LUM696811)  
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)  
POLYURETHANE-35 (NOT MORE THAN 1000 MPA.S AT 40%) (UNII: M50EV976QC)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
POLYSORBATE 61 (UNII: X9E1MY2JQG)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
DIMETHICONOL (70 CST) (UNII: MOT8IL21AR)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-520-01142 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/201810/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only01/01/201810/31/2023
Labeler - L'OREAL USA PRODUCTS INC (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA, INC624244349manufacture(49967-520) , pack(49967-520)

Revised: 2/2024
 
L'OREAL USA PRODUCTS INC