CERAVE SUNSCREEN BROAD SPECTRUM SPF 50 BODY- titanium dioxide, zinc oxide lotion 
Bausch Health US, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CeraVe®
Body Lotion
Sunscreen Broad Spectrum SPF 50

Drug Facts

Active IngredientsPurpose

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)

CeraVe SPF 50 Sunscreen Body Lotion Carton
CERAVE  SUNSCREEN BROAD SPECTRUM SPF 50 BODY
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-2204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide4.165 g  in 85 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide3.995 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-2204-0185 g in 1 TUBE; Type 0: Not a Combination Product12/25/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/25/201205/14/2021
Labeler - Bausch Health US, LLC (831922468)

Revised: 2/2017
 
Bausch Health US, LLC