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Gillette Fusion ProSeries Instant Hydration UV Moisturizer SPF 15

Dosage form: lotion
Ingredients: Avobenzone 29.4mg in 1mL, Homosalate 49mg in 1mL, Octisalate 49mg in 1mL, Octocrylene 25.4mg in 1mL
Labeler: Procter & Gamble Manufacturing Company
NDC Code: 37000-271

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.

Gillette®
Fusion®
PROSERIES™

Directions

Apply evenly to face and neck after shaving or as needed.

WARNING

FOR EXTERNAL USE ONLY.

NOT TO BE SWALLOWED. AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR.

KEEP OUT OF REACH OF CHILDREN.

ACTIVE INGREDIENTS

3.0% AVOBENZONE, 5.0% HOMOSALATE, 5.0% OCTISALATE, 2.6% OCTOCRYLENE.

INACTIVE INGREDIENTS

WATER, GLYCERIN, NIACINAMIDE, POLYETHYLENE, DIMETHICONE, PENTYLENE GLYCOL, ISOHEXADECANE, PANTHENOL, TOCOPHERYL ACETATE, BENZYL ALCOHOL, STEARYL ALCOHOL, BEHENYL ALCOHOL, CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, POLYSORBATE 60, CETYL ALCOHOL, DIMETHICONOL, PEG-100 STEARATE, STEARIC ACID, IODOPROPYNYL BUTYLCARBAMATE, PEG-4, PEG-4 LAURATE, PEG-4 DILAURATE, DISODIUM EDTA, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, FRAGRANCE.

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PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

Gillette®
Fusion®

PROSERIES™

INSTANT HYDRATION
UV MOISTURIZER

SPF
+15

Conditions & Protects
Just Shaved Skin

1.7 FL OZ (50 mL)

GILLETTE FUSION PROSERIES INSTANT HYDRATION UV MOISTURIZER   SPF 15
avobenzone, homosalate, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-271
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone29.4 mg  in 1 mL
Homosalate (Homosalate) Homosalate49 mg  in 1 mL
Octisalate (Octisalate) Octisalate49 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene25.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
NIACINAMIDE 
DIMETHICONE 
PENTYLENE GLYCOL 
ISOHEXADECANE 
PANTHENOL 
BENZYL ALCOHOL 
STEARYL ALCOHOL 
DOCOSANOL 
CETEARYL GLUCOSIDE 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
CETYL ALCOHOL 
PEG-100 STEARATE 
STEARIC ACID 
IODOPROPYNYL BUTYLCARBAMATE 
POLYETHYLENE GLYCOL 200 
PEG-4 LAURATE 
PEG-4 DILAURATE 
EDETATE DISODIUM 
METHYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:37000-271-501 BOTTLE, PUMP in 1 CARTON
150 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/01/201103/10/2014
Labeler - Procter & Gamble Manufacturing Company (004238200)
Establishment
NameAddressID/FEIOperations
Olay Company LLC090475799MANUFACTURE(37000-271)

Revised: 07/2012
Document Id: f89ba63d-a0a2-4bb7-ac51-298074d556b9
Set id: 551c8a7b-710b-4e4f-99ae-4d0d13e44c90
Version: 2
Effective Time: 20120709
 
Procter & Gamble Manufacturing Company

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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