Label: ALMAY AGE ESSENTIALS MAKEUP SPF 15- octinoxate, titanium dioxide make-up liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0311-0707-01 - Packager: Almay, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 2, 2016
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- Active Ingredients:
- Purpose
- Uses:
- Warnings:
- Directions
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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 am - 2 pm
•Wear long-sleeved shirts, pants, hats and sunglasses. -
Inactive Ingredients
Aqua ((Water) Eau), — Cyclopentasiloxane, — Dimethicone, — Phenyl Trimethicone, — Glycerin, — PEG-9 Polydimethylsiloxyethyl Dimethicone, — Boron Nitride, — Trimethylsiloxysilicate, — Disteardimonium Hectorite, — Atelocollagen, — Soluble Collagen, Tripeptide-29, — Hyaluronic Acid, — Tocopherol, — Palmitoyl Tripeptide-5, — Acetyl Hexapeptide-8, — Sodium Hyaluronate, — Hydrolyzed Glycosaminoglycans, — Methyl Acetylglycyrrhetinoyl Hydroxyprolinate, — Glycyrrhetinic Acid, — Niacinamide, — Sodium Ascorbyl Phosphate, — Acetyl Hydroxyproline, — Pullulan, — Sorbitol, — Trehalose, — Dimethicone/PEG-10/15 Crosspolymer, — Alumina, — Laureth-7, — Polyglyceryl-3 Diisostearate, — Silica, — Sodium Chloride, — Methicone, — Dimethicone Crosspolymer, — Triethoxycaprylylsilane, — Xanthan Gum, — Phospholipids, — Calcium Aluminum Borosilicate, — Tetrasodium EDTA, — Tocopheryl Acetate, — C12-15 Alkyl Benzoate, — Sodium Chondroitin Sulfate, — Acacia Senegal Gum, — Dipropylene Glycol, — Sodium Citrate, — Propylene Glycol, — Linoleic Acid, — Lecithin, — Phytosteryl Canola Glycerides, — Oleic Acid, — Palmitic Acid, — Stearic Acid, — Triolein, Phenoxyethanol, — Caprylyl Glycol, — Potassium Sorbate
May Contain, — Mica, — Titanium Dioxide (CI 77891), — Iron Oxides (CI 77491, 77492, 77499),
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INGREDIENTS AND APPEARANCE
ALMAY AGE ESSENTIALS MAKEUP SPF 15
octinoxate, titanium dioxide make-up liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0311-0707 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) METHICONE (20 CST) (UNII: 6777U11MKT) LAURETH-7 (UNII: Z95S6G8201) ALUMINUM OXIDE (UNII: LMI26O6933) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8RD4) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) BORON NITRIDE (UNII: 2U4T60A6YD) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CHLORIDE (UNII: 451W47IQ8X) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) TOCOPHEROL (UNII: R0ZB2556P8) LINOLEIC ACID (UNII: 9KJL21T0QJ) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PALMITIC ACID (UNII: 2V16EO95H1) OLEIC ACID (UNII: 2UMI9U37CP) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETATE SODIUM (UNII: MP1J8420LU) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) PULLULAN (UNII: 8ZQ0AYU1TT) SORBITOL (UNII: 506T60A25R) TREHALOSE (UNII: B8WCK70T7I) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) ENOXOLONE (UNII: P540XA09DR) OXACEPROL (UNII: Q0XV76B96L) ACACIA (UNII: 5C5403N26O) DIPROPYLENE GLYCOL (UNII: E107L85C40) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) GLYCYLHYDROXYPROLYLPROLINE (UNII: 2Y6E8387T3) HYALURONIC ACID (UNII: S270N0TRQY) SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) GLYCERYL TRIOLEATE (UNII: O05EC62663) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0311-0707-01 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/18/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/18/2016 Labeler - Almay, Inc. (064988652) Establishment Name Address ID/FEI Business Operations REVLON, INC. 809725570 manufacture(0311-0707)