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CeraVe

Valeant Pharmaceuticals North America LLC

CeraVe AMFacial Moisturizing LotionSUNSCREENBROAD SPECTRUM 30 SPF


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredient Purpose
Homosalate 12% Sunscreen
Octinoxate 7.5% Sunscreen
Zinc Oxide 3.5% Sunscreen
Octocrylene 2% Sunscreen
  • Provides patented controlled release of ingredients to help repair and restore your skin's natural protective barrier.
  • For external use only, not to be swallowed.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.
  • 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.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.

Purified Water, Niacinamide, Behentrimonium Methosulfate and Cetearyl Alcohol, Glycerin, Aluminum Starch Octenylsuccinate and Boron Nitride, Dimethicone, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Hyaluronic Acid, Phytosphingosine, Hydroxyethylcellulose, Disodium EDTA, Sodium Lauroyl Lactylate, Methylparaben, Propylparaben, Carbomer, Xanthan Gum

www.CeraVe.com

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

129854-0612

PRINCIPAL DISPLAY PANEL - 3 FL OZ Bottle

CeraVe ®
DEVELOPED WITH DERMATOLOGISTS

AM

Facial Moisturizing Lotion

SUNSCREEN

BROAD SPECTRUM 30 SPF

FOR NORMAL TO DRY SKIN

MVE DELIVERY TECHNOLOGY

Provides patented controlled release of ingredients to help repair and restore your skin's natural protective barrier.

Non-comedogenic, non-irritating

With ceramides, niacinamide, and hyaluronic acid

3 FL OZ (89 mL)

CeraVe

CeraVe

Homosalate, Octinoxate, Zinc Oxide, and Octocrylene LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0187-1366
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 124 mg
OCTINOXATE OCTINOXATE 77 mg
Zinc Oxide Zinc oxide 36 mg
OCTOCRYLENE Octocrylene 21 mg

Inactive Ingredients

Ingredient Name Strength
water
NIACINAMIDE
BEHENTRIMONIUM METHOSULFATE
CETOSTEARYL ALCOHOL
GLYCERIN
ALUMINUM STARCH OCTENYLSUCCINATE
BORON NITRIDE
DIMETHICONE 20
CERAMIDE 3
CERAMIDE 6 II
CERAMIDE 1
CHOLESTEROL
HYALURONIC ACID
phytosphingosine
EDETATE DISODIUM
SODIUM LAUROYL LACTYLATE
METHYLPARABEN
PROPYLPARABEN
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0187-1366-03 89 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-10-02


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