GARNIER OMBRELLE SPF 15 COMPLETE- avobenzone, ensulizole, octocrylene and terephthalylidene dicamphor sulfonic acid lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Avobenzone 3%

Ensulizole 1.5%

Octocrylene 10%

Terephthalylidene Dicamphor Sulfonic Acid 1%

Warnings

For external use only. Do not use on damaged or broken skin. If rash occurs, discontinue use and consult a health care practitioner. Keep out of eyes. 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.

Inactive ingredients

water, cyclopentasiloxane, glycerin, propylene glycol, isopropyl palmitate, triethanolamine, alcohol denat., VP/eicosene copolymer, dimethicone, panthenol, PEG-100 stearate, glyceryl stearate, phenoxyethanol, stearic acid, methylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol, disodium EDTA, xanthan gum, butylparaben, ethylparaben, PEG-4 dilaurate, PEG-4 laurate, isobutylparaben, propylparaben, iodopropynyl butylcarbamate

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GARNIER OMBRELLE SPF 15 COMPLETE 
avobenzone, ensulizole, octocrylene and terephthalylidene dicamphor sulfonic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE15 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439) ECAMSULE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALCOHOL (UNII: 3K9958V90M)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
PEG-4 DILAURATE (UNII: KCR71CW036)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-001-011 in 1 CARTON01/01/201708/09/2021
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-001-021 in 1 CARTON01/01/2017
2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only01/01/201708/09/2021
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA, INC.624244349manufacture(49967-001) , pack(49967-001)

Revised: 1/2023
Document Id: 651b124d-9040-4f18-922f-2ef4c31eb792
Set id: 118c7695-7f83-4885-9733-814d48f51b5b
Version: 5
Effective Time: 20230129
 
L'Oreal USA Products Inc