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CeraVe

Valeant Pharmaceuticals North America LLC

CeraVe Wet Skin Spray SPF 50


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 15% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Oxybenzone 6% Sunscreen
  • Helps prevent sunburn
  • For external use only
  • Flammable: Do not use near heat, flame, or while smoking.
  • Do not use on damaged or broken skin.
  • When using this product
    • Keep out of eyes. Rinse eyes with water to remove.
    • Keep away from face to avoid breathing it.
    • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F
  • Stop use and ask a doctor if rash occurs
  • Keep out of reach of children.
    If product is swallowed, get medical help or contact a Poison Control Center right away.
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in a well-ventilated area
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Alcohol Denat., Octyldodecyl Citrate Crosspolymer, Polyester-7, Neopentyl Glycol Diheptanoate, Cyclopentasiloxane, Acrylates/Octylacrylamide Copolymer, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Phytosphingosine, Sodium Hyaluronate, Polyester-8, Acrylates/Dimethicone Copolymer, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Dimethicone, Nelumbo Nucifera Wax, Carbomer, Xanthan Gum, Sodium Lauroyl Lactylate

  • protect this product from excessive heat and direct sun
  • may stain fabrics

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-WET50-36
09/12

PRINCIPAL DISPLAY PANEL - 5.0 OZ Wet Skin Spray

NEW

CeraVe ®
DEVELOPED WITH DERMATOLOGISTS

Sunscreen
BROAD SPECTRUM SPF 50

WET SKIN SPRAY
SPF 50

Applies on wet or dry skin

Lightweight, oil-free

Water resistant (80 minutes)

With ceramides and hyaluronic acid

Net Wt. 5.0 OZ (141 g)

CeraVe

CeraVe

Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0187-2206
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 4.23 g
HOMOSALATE Homosalate 21.15 g
OCTISALATE OCTISALATE 7.05 g
OCTOCRYLENE Octocrylene 14.10 g
OXYBENZONE OXYBENZONE 8.46 g

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
Polyester-7
NEOPENTYL GLYCOL DIHEPTANOATE
CYCLOMETHICONE 5
CERAMIDE 3
CERAMIDE 6 II
CERAMIDE 1
CHOLESTEROL
phytosphingosine
HYALURONATE SODIUM
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
.ALPHA.-TOCOPHEROL ACETATE
VITAMIN A PALMITATE
ASCORBYL PALMITATE
DIMETHICONE
Nelumbo Nucifera Flower Wax
XANTHAN GUM
SODIUM LAUROYL LACTYLATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0187-2206-01 141 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-11-28


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