GARNIER OMBRELLE SPF 45 KIDS HYPOALLERGENIC- oxybenzone, octisalate, titanium dioxide, octocrylene and terephthalylidene dicamphor sulfonic acid lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Oxybenzone 5%

Octisalate 5%

Titanium Dioxide 4.2%

Octocrylene 3.5%

Terephthalylidene Dicamphor Sulfonic Acid 3%

Avobenzone 2%

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 ouf 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 Center right away. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

Directions

Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. For use on children less than 6 months of age, consult a health care practitioner.

image of a label

GARNIER OMBRELLE SPF 45 KIDS HYPOALLERGENIC 
oxybenzone, octisalate, titanium dioxide, octocrylene and terephthalylidene dicamphor sulfonic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-493
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE42 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE35 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE30 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ALCOHOL (UNII: 3K9958V90M)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PANTHENOL (UNII: WV9CM0O67Z)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-493-011 in 1 CARTON09/24/2011
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-493-021 in 1 CARTON09/24/2011
2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only09/24/2011
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.624244349manufacture(49967-493) , pack(49967-493)

Revised: 1/2020
Document Id: f9d6db67-4f28-4048-82b3-1a8430256f34
Set id: e26e4b74-d1ba-4e0f-935b-8d52f792bb8c
Version: 2
Effective Time: 20200117
 
L'Oreal USA Products Inc