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 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Homosalate 10.7%
Octocrylene 6%
Oxybenzone 3.9%
Octisalate 3.2%
Avobenzone 3%
Drometrizole Trisiloxane 0.5%

Others

Aqua, Alcohol Denat., Dimethicone, Styrene/Acrylates Copolymer, Acrylates/Dimethicone Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylyl Glycol, Disodium EDTA, PEG-8 Laurate, Phenoxyethanol, Sodium Dodecylbenzenesulfonate, Sodium Polyacrylate, Tocopherol

Technology

Ombrelle’s patented filtering system with Mexoryl technology and other sunscreen filters provides effective broad-spectrum UVA/UVB protection and helps prevent sunburns.

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.

image of a label

image of a 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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49967-704
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE107 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE39 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE32 mg  in 1 mL
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
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-704-011 in 1 CARTON01/19/2019
1200 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-704-021 in 1 CARTON01/19/2019
290 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:49967-704-036 mL in 1 PACKET; Type 0: Not a Combination Product01/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only01/19/2019
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA PRODUCTS, INC.624244349manufacture(49967-704)

Revised: 12/2023
Document Id: 21c57fa3-19cd-4d6f-a1ef-a61cc473fc52
Set id: e1f4208b-3f24-4e01-b53f-c1778ea5c1b3
Version: 5
Effective Time: 20231231
 
L'Oreal USA Products Inc