OIL CONTROL MATTIFIER SPF 15- ensulizole, octinoxate, octinoxate cream

Oil Control Mattifier SPF 15 by

Drug Labeling and Warnings

Oil Control Mattifier SPF 15 by is a Otc medication manufactured, distributed, or labeled by Murad, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Ensulizole 1.0%

Octinoxate 7.5%

Zinc Oxide 3.0%

Purpose

Sunscreen

Use

• helps prevent sunburn

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 skin rash occurs

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 at least every 2 hours and immediately after towel drying, swimming, or sweating to avoid lowering protection  children under 6 months: Ask a doctor

Inactive ingredients

Water (Aqua), Cyclopentasiloxane, Bis-PEG/PPG-14/14 Dimethicone, Dimethicone Crosspolymer, Urea, Yeast Amino Acids, Trehalose, Inositol, Taurine, Betaine, Phospholipids, Retinyl Palmitate, Tocopheryl Acetate, Ascorbyl Palmitate, Polyglyceryl-3 Polydimethylsiloxyethyl
Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Farnesyl Acetate, Panthenyl Triacetate, Argania Spinosa Kernel Oil, Serenoa Serrulata Fruit Extract, Sesamum Indicum (Sesame) Seed Oil, Beta-Sitosterol, Punica Granatum Seed Oil, Capryloyl Glycine, Sarcosine, Cinnamomum Zeylanicum Bark Extract, Aluminum Starch Octenylsuccinate, Ascorbic Acid, Butylene Glycol, Chitosan, Propyl Gallate, Acrylates Copolymer, Magnesium Carbonate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Corn Starch Modified, Zinc Gluconate, Acrylates Crosspolymer, Salix Alba (Willow) Bark Extract, Aminomethyl Propanol, Disodium EDTA, Sodium Chloride, Phenoxyethanol, Chlorphenesin

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

1.800.33.MURAD or Murad.com

Package Labeling:

INGREDIENTS AND APPEARANCE

OIL CONTROL MATTIFIER SPF 15 
ensulizole, octinoxate, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70381-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	10 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
TREHALOSE (UNII: B8WCK70T7I)
INOSITOL (UNII: 4L6452S749)
TAURINE (UNII: 1EQV5MLY3D)
BETAINE (UNII: 3SCV180C9W)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FARNESYL ACETATE (UNII: 2ARF3ZNJ1R)
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
ARGAN OIL (UNII: 4V59G5UW9X)
SAW PALMETTO (UNII: J7WWH9M8QS)
SESAME OIL (UNII: QX10HYY4QV)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
SARCOSINE (UNII: Z711V88R5F)
CINNAMON BARK OIL (UNII: XE54U569EC)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLENE GLYCOL 2-LAURATE (UNII: 80K4P9IZ6H)
PROPYL GALLATE (UNII: 8D4SNN7V92)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
TEA TREE OIL (UNII: VIF565UC2G)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
SALIX ALBA BARK (UNII: 205MXS71H7)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70381-001-10	1 in 1 CARTON	12/31/2015
1		10 mL 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	12/31/2015

Labeler - Murad, Inc. (963333807)