SUNSCREEN SPF 50 CERAVE- titanium dioxide - 4.90% zinc oxide - 4.70% 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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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 messures (see ​Directions​) decreases the risk of skin cancer and early skin aging caused by sun.

Warnings

For external use only
Do not use on damaged or broken skin
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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • at least every 2 hours
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

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, Niacinamide, 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, Ehtylhexylglycerin, 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.

image description
SUNSCREEN SPF 50  CERAVE
titanium dioxide - 4.90% zinc oxide - 4.70% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66490-555
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.9 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
Dimethicone (UNII: 92RU3N3Y1O)  
ACRYLIC ACID (UNII: J94PBK7X8S)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
Dimethicone PEG-8 Laurate (UNII: 72MF9C2A18)  
Isohexadecane (UNII: 918X1OUF1E)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Trisiloxane (UNII: 9G1ZW13R0G)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Ceramide 1 (UNII: 5THT33P7X7)  
Niacinamide (UNII: 25X51I8RD4)  
Cholesterol (UNII: 97C5T2UQ7J)  
Phytosphingosine (UNII: GIN46U9Q2Q)  
PEG-100 Stearate (UNII: YD01N1999R)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
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)  
Glycerin (UNII: PDC6A3C0OX)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
Xanthan Gum (UNII: TTV12P4NEE)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
Sodium Lauroyl Lactylate (UNII: 7243K85WFO)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
Methylisothiazolinone (UNII: 229D0E1QFA)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
POLIHEXANIDE (UNII: 322U039GMF)  
CERAMIDE AP (UNII: F1X8L2B00J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66490-555-021 in 1 CARTON12/12/201208/01/2017
156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/12/201208/01/2018
Labeler - Bausch Health US LLC (831922468)

Revised: 11/2015
 
Bausch Health US LLC