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CeraVe

Valeant Pharmaceuticals North America LLC

CeraVe Sunscreen Broad Spectrum SPF 30BODY LOTION


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredient Purpose
Homosalate 5% Sunscreen
Meradimate 5% Sunscreen
Octinoxate 5% Sunscreen
Titanium Dioxide 2.5% Sunscreen
Zinc Oxide 23.65% 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 40 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/Eau, C12-15 Alkyl Benzoate, Cyclotetrasiloxane, Butyloctyl Salicylate, Cyclopentasiloxane, Aluminum Starch Octenylsuccinate, Butylene Glycol, Sorbitan Sesquioleate, Dimethicone, Isostearic Acid, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Phytosphingosine, Sodium Hyaluronate, Disteardimonium Hectorite, Phenoxyethanol, Magnesium Sulfate, Sodium Chloride, Polyhydroxystearic Acid, Sodium Polycrylate, Propylene Carbonate, Triethoxycaprylylsilane, PEG/PPG 18/18 Dimethicone, Ethylhexylglycerin, Trideceth-6, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum

  • 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

Made in Canada

50099120A
06/12

PRINCIPAL DISPLAY PANEL - 3.5 oz. Tube

NEW

CeraVe ®
DEVELOPED WITH DERMATOLOGISTS

Sunscreen
BROAD SPECTRUM SPF 30

BODY LOTION
SPF 30

InVisibleZinc TM

Lightweight, and oil-free

Water Resistant (40 minutes)

With ceramides and hyaluronic acid

Net Wt. 3.5 OZ (99g)

CeraVe

CeraVe

Homosalate, Meradimate, Octinoxate, Titanium Dioxide, and Zinc Oxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0187-2200
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 4.95 g
MERADIMATE Meradimate 4.95 g
OCTINOXATE OCTINOXATE 4.95 g
titanium dioxide 2.48 g
Zinc Oxide Zinc oxide 23.41 g

Inactive Ingredients

Ingredient Name Strength
water
ALKYL (C12-15) BENZOATE
CYCLOMETHICONE 4
BUTYLOCTYL SALICYLATE
CYCLOMETHICONE 5
ALUMINUM STARCH OCTENYLSUCCINATE
BUTYLENE GLYCOL
SORBITAN SESQUIOLEATE
DIMETHICONE 1000
isostearic acid
PHENYL TRIMETHICONE
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
CERAMIDE 3
CERAMIDE 6 II
CERAMIDE 1
CHOLESTEROL
phytosphingosine
HYALURONATE SODIUM
PHENOXYETHANOL
MAGNESIUM SULFATE
SODIUM CHLORIDE
POLYHYDROXYSTEARIC ACID (2300 MW)
PROPYLENE CARBONATE
TRIETHOXYCAPRYLYLSILANE
PEG/PPG-18/18 DIMETHICONE
ETHYLHEXYLGLYCERIN
TRIDECETH-6
SODIUM LAUROYL LACTYLATE
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0187-2200-01 99 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-08-27


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