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Kiehls Since 1851 Facial Fuel UV Guard Fast Absorbing Sunscreen for Men SPF 50 Plus

Dosage form: lotion
Ingredients: Avobenzone 1.5mL in 50mL, Homosalate 7.5mL in 50mL, Octisalate 2.5mL in 50mL, Octocrylene 2.5mL in 50mL, Oxybenzone 3mL in 50mL
Labeler: L'Oreal USA Products Inc.
NDC Code: 49967-279

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Purpose

Sunscreen

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 40 minutes of activity in the water
  • provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin

Warnings

For external use only

Stop use and ask a doctor if rash or irritation develops or lasts

When using this product keep out of eyes. Rinse to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • apply liberally before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • shake well before using/applying

Inactive ingredients

water, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates, copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, PEG-8 laurate, methylparaben, tocopherol, poly c10-30 alkyl acrylate, disteardimonium hectorite, isostearyl alcohol, caffeine, ascorbyl glucoside, disodium EDTA, dodecene, poloxamer 407

KIEHLS SINCE 1851 FACIAL FUEL UV GUARD  FAST ABSORBING SUNSCREEN FOR MEN SPF 50 PLUS
avobenzone homosalate octisalate octocrylene oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-279
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone1.5 mL  in 50 mL
Homosalate (Homosalate) Homosalate7.5 mL  in 50 mL
Octisalate (Octisalate) Octisalate2.5 mL  in 50 mL
Octocrylene (Octocrylene) Octocrylene2.5 mL  in 50 mL
Oxybenzone (Oxybenzone) Oxybenzone3 mL  in 50 mL
Packaging
#Item CodePackage Description
1NDC:49967-279-011 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
150 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2011
Labeler - L'Oreal USA Products Inc. (002136794)
Establishment
NameAddressID/FEIOperations
Cosmetic Essence, LLC032565959manufacture
Establishment
NameAddressID/FEIOperations
L'Oreal USA Products Inc.185931458analysis

Revised: 08/2011
Document Id: d65bec5f-0428-46ba-80a9-9ffa201ccb56
Set id: 081200d8-6bda-4736-b1d2-78b3816847e8
Version: 3
Effective Time: 20110825
 
L'Oreal USA Products Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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