Label: GARNIER OMBRELLE KIDS ULTRA GENTLE BROAD SPECTRUM SPF 50 PLUS SUNSCREEN WATER RESISTANT 80 MINUTES- avobenzone, drometrizole trisiloxane, homosalate, octisalate and octocrylene spray
- NDC Code(s): 49967-249-01
- 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
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 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, 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, sodium dodecylbenzenesulfonate, methylpropanediol, phenylpropanol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE KIDS ULTRA GENTLE 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:49967-249 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) 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 (100000 CST) (UNII: OSA9UP217S) 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:49967-249-01 122 mL in 1 CONTAINER; Type 0: Not a Combination Product 10/18/2021 02/28/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date export only 10/18/2021 02/28/2026 Labeler - L'OREAL USA PRODUCTS INC (002136794) Establishment Name Address ID/FEI Business Operations L'OREAL USA, INC 624244349 manufacture(49967-249)
