Label: GARNIER OMBRELLE SPF 60 UVA UVB KIDS WET N PROTECT SUNSCREEN PROTECTION EVEN ON WET SKIN HYPOALLERGENIC WATER/SWEAT RESISTANT 80 MINUTES QUICK ABSORPTION- homosalate, octocrylene, oxybenzone, octisalate, avobenzone and drometrizole trisiloxane lotion
- NDC Code(s): 49967-704-01, 49967-704-02, 49967-704-03
- Packager: L'Oreal USA Products Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated December 31, 2023
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Direction
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. For use on children less than 6 months of age, consult a health care practitioner.
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: limiting time in the sun, especially from 10 a.m. – 2 p.m., and wearing long-sleeved shirts, pants, hats, and sunglasses. -
Caution
For external use only. Do not use on damaged or broken skin. If rash occurs, discontinue use and consult a health care practitioner. Keep product out of eyes. IF contact occurs, rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away. Do not expose babies and young children directly to the sun. Avoid contact with textiles.
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INGREDIENTS AND APPEARANCE
GARNIER OMBRELLE SPF 60 UVA UVB KIDS WET N PROTECT SUNSCREEN PROTECTION EVEN ON WET SKIN HYPOALLERGENIC WATER/SWEAT RESISTANT 80 MINUTES QUICK ABSORPTION
homosalate, octocrylene, oxybenzone, octisalate, avobenzone and drometrizole trisiloxane lotionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49967-704 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 107 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 39 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 32 mg in 1 mL 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ALCOHOL (UNII: 3K9958V90M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) PEG-8 LAURATE (UNII: 762O8IWA10) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-704-01 1 in 1 CARTON 01/19/2019 1 200 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-704-02 1 in 1 CARTON 01/19/2019 2 90 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:49967-704-03 6 mL in 1 PACKET; Type 0: Not a Combination Product 01/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date export only 01/19/2019 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'OREAL USA PRODUCTS, INC. 624244349 manufacture(49967-704)
