SUNSCREEN SPF 50 CERAVE- titanium dioxide - 4.90% zinc oxide - 4.70% lotion

Sunscreen SPF 50 by

Drug Labeling and Warnings

Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                                    Purpose

Titanium Dioxide 4.9%                             Sunscreen

Zinc Oxide 4.7%                                       Sunscreen

PURPOSE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 50  CERAVE
titanium dioxide - 4.90% zinc oxide - 4.70% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66490-555
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	4.9 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 3 (UNII: 4370DF050B)
Ceramide 6 II (UNII: F1X8L2B00J)
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)
Polyaminopropyl Biguanide (UNII: 322U039GMF)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66490-555-02	1 in 1 CARTON
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/12/2012

Labeler - Valeant Pharmaceuticals (831922468)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(66490-555)