CERAVE SUNSCREEN BROAD SPECTRUM SPF 50 BODY- titanium dioxide, zinc oxide lotion

CeraVe by

Drug Labeling and Warnings

CeraVe by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 4.9%	Sunscreen
Zinc Oxide 4.7%	Sunscreen

Uses

• 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

Warnings

• 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.

Directions

• 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

Inactive Ingredients

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, 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.

Other Information

• Protect this product from excessive heat and direct sun

Questions?

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

PRINCIPAL DISPLAY PANEL - 3.0 oz SPF 50 Body Lotion

CeraVe®
DEVELOPED WITH DERMATOLOGISTS

Sunscreen
BROAD SPECTRUM SPF 50

BODY LOTION SPF 50

InVisibleZinc®

Lightweight and oil-free

Water resistant (40 minutes)

With ceramides

Net Wt. 3.0 OZ (85 g)

INGREDIENTS AND APPEARANCE

CERAVE  SUNSCREEN BROAD SPECTRUM SPF 50 BODY
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-2204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	4.165 g  in 85 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.995 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)
ISOHEXADECANE (UNII: 918X1OUF1E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TRISILOXANE (UNII: 9G1ZW13R0G)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
OAT (UNII: Z6J799EAJK)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
YELLOW WAX (UNII: 2ZA36H0S2V)
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STEARIC ACID (UNII: 4ELV7Z65AP)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
XANTHAN GUM (UNII: TTV12P4NEE)
POLIHEXANIDE (UNII: 322U039GMF)
ALUMINUM OXIDE (UNII: LMI26O6933)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-2204-01	85 g in 1 TUBE; Type 0: Not a Combination Product	12/25/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/25/2012

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	MANUFACTURE(0187-2204)