Label: GARNIER OMBRELLE ULTRA LIGHT ADVANCED BROAD SPECTRUM SPF 50 PLUS SUNSCREEN WATER RESISTANT 80 MINUTES- avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene spray
- NDC Code(s): 49967-696-01
- Packager: L'OREAL USA PRODUCTS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated February 1, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
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Warnings
For external use only.
Do not use on broken skin.
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly
with water.
Stop use and ask a doctor if rash occurs.
Other warnings Contents under pressure. Do not place in hot water or near radiators,
stoves or other sources of heat. Do not puncture or incinerate container or store
at temperatures over 50 °C.
Keep out of reach of children. If swallowed, call a poison control centre or get
medical help right away. -
Directions
Adults and adolescents 12 to 17 years • 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 hands, then
apply to face • Do not apply in windy conditions • Use in a well-ventilated area •
Avoid inhaling or exposing others to spray • Reapply at least every 2 hours • Reapply
after 80 minutes of swimming or sweating • Reapply immediately after towel drying
• 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 measures
including: • limit time in the sun, especially from 11 a.m. – 3 p.m. ; and • wear
long-sleeved shirts, pants, hats, and sunglasses. -
Others
aqua/water, dimethicone, glycerin, butyloctyl salicylate, isopropyl lauroyl sarcosinate, styrene/acrylates copolymer, isotridecyl isononanoate, polyurethane-35, caprylyl methicone, octyldodecanol, phenoxyethanol, caprylyl glycol, sodium stearoyl glutamate,
polysorbate 61, glyceryl stearate, PEG-8 laurate, dimethiconol, octyldodecyl xyloside, PEG-12 dimethicone, p-anisic acid, stearyl alcohol, tocopherol, disodium EDTA, sodium dodecylbenzenesulfonate, methylpropanediol, phenylpropanol - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE ULTRA LIGHT ADVANCED BROAD SPECTRUM SPF 50 PLUS SUNSCREEN WATER RESISTANT 80 MINUTES
avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-696 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 150 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) SORBITAN TRISTEARATE (UNII: 6LUM696811) ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) POLYURETHANE-35 (NOT MORE THAN 1000 MPA.S AT 40%) (UNII: M50EV976QC) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) OCTYLDODECANOL (UNII: 461N1O614Y) 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 (100000 CST) (UNII: OSA9UP217S) OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) P-ANISIC ACID (UNII: 4SB6Y7DMM3) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) METHYLPROPANEDIOL (UNII: N8F53B3R4R) PHENYLPROPANOL (UNII: 0F897O3O4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-696-01 122 mL in 1 CONTAINER; Type 0: Not a Combination Product 10/18/2021 09/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date export only 10/18/2021 09/30/2025 Labeler - L'OREAL USA PRODUCTS INC (002136794) Establishment Name Address ID/FEI Business Operations L'OREAL USA, INC 960317444 manufacture(49967-696)
