GILLETTE FUSION PROSERIES INSTANT HYDRATION UV MOISTURIZER SPF 15 - avobenzone, homosalate, octisalate and octocrylene lotion
Procter & Gamble Manufacturing Company

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.

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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)

Principal Display Panel - 50 mL Bottle Label

GILLETTE FUSION PROSERIES INSTANT HYDRATION UV MOISTURIZER SPF 15
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-271
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (Avobenzone)	Avobenzone	29.4 mg in 1 mL
Homosalate (Homosalate)	Homosalate	49 mg in 1 mL
Octisalate (Octisalate)	Octisalate	49 mg in 1 mL
Octocrylene (Octocrylene)	Octocrylene	25.4 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37000-271-50	1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON	contains a BOTTLE, PUMP
1		50 mL in 1 BOTTLE, PUMP	This package is contained within the CARTON (37000-271-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2011

Labeler - Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Operations
Olay Company LLC		090475799	MANUFACTURE

Revised: 08/2011 Procter & Gamble Manufacturing Company