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CeraVe

Valeant Pharmaceuticals North America LLC

CeraVe Face LotionSunscreen Broad Spectrum SPF 50


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients Purpose
Titanium Dioxide 4.9% Sunscreen
Zinc Oxide 4.7% Sunscreen
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
  • For external use only
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product 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.
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
  • Children under 6 months: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses

Water, Butyloctyl Salicylate, Cetyl Dimethicone, Dimethicone, Styrene/Acrylates Copolymer, Trimethylsiloxysilicate, Dimethicone PEG-8 Laurate, Isohexadecane, Butylene Glycol, Polysorbate 60, Trisiloxane, Arachidyl Alcohol, Polyhydroxystearic Acid, Hydrated Silica, Ceramide 3, Ceramide 6-II, Ceramide 1, Niacinamide, Cholesterol, Phytosphingosine, PEG-100 Stearate, Glyceryl Stearate, Ascorbic Acid, Avena Sativa (Oat) Kernel Extract, Arachidyl Glucoside, Beeswax, Behenyl Alcohol, Benzyl Alcohol, Stearic Acid, Bisabolol, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pantothenic Acid/Yeast Polypeptide, PEG-8, Xanthan Gum, Polyaminopropyl Biguanide, Polymethyl Methacrylate, Alumina, Potassium Sorbate, Retinyl Palmitate, Sodium Lauroyl Lactylate, Carbomer, Tocopheryl Acetate, BHT, Disodium EDTA, Methicone, Methylisothiazolinone, Triethoxycaprylylsilane.

  • Protect this product from excessive heat and direct sun

Toll-free number (800) 321-4576
www.CeraVe.com

Distributed by:
Valeant Consumer Products, a Division of Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807

VNT-50FAC-25
09/12

PRINCIPAL DISPLAY PANEL - 2.0 oz SPF 50 Face Lotion

NEW

CeraVe ®
DEVELOPED WITH DERMATOLOGISTS

Sunscreen
BROAD SPECTRUM SPF 50

FACE LOTION
SPF 50

InVisibleZinc

Lightweight and oil-free

Water resistant (80 minutes)

With ceramides and niacinamide

Net Wt. 2.0 OZ (56 g)

CeraVe

CeraVe

Titanium Dioxide, Zinc Oxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0187-2205
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 2.744 g
Zinc Oxide Zinc oxide 2.632 g

Inactive Ingredients

Ingredient Name Strength
water
BUTYLOCTYL SALICYLATE
DIMETHICONE
DIMETHICONE PEG-8 LAURATE
Isohexadecane
BUTYLENE GLYCOL
POLYSORBATE 60
Trisiloxane
ARACHIDYL ALCOHOL
HYDRATED SILICA
CERAMIDE 3
CERAMIDE 6 II
CERAMIDE 1
NIACINAMIDE
CHOLESTEROL
phytosphingosine
PEG-100 STEARATE
GLYCERYL MONOSTEARATE
ASCORBIC ACID
OAT
ARACHIDYL GLUCOSIDE
YELLOW WAX
docosanol
BENZYL ALCOHOL
STEARIC ACID
LEVOMENOL
GLYCYRRHIZINATE DIPOTASSIUM
ETHYLHEXYLGLYCERIN
GLYCERIN
polyethylene glycol 400
XANTHAN GUM
POLYAMINOPROPYL BIGUANIDE
ALUMINUM OXIDE
POTASSIUM SORBATE
VITAMIN A PALMITATE
SODIUM LAUROYL LACTYLATE
.ALPHA.-TOCOPHEROL ACETATE
BUTYLATED HYDROXYTOLUENE
EDETATE DISODIUM
METHYLISOTHIAZOLINONE
TRIETHOXYCAPRYLYLSILANE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0187-2205-01 56 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-12-25


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