ALMAY AGE ESSENTIALS MAKEUP SPF 15- octinoxate, titanium dioxide make-up liquid

Almay Age Essentials Makeup SPF 15 by

Drug Labeling and Warnings

Almay Age Essentials Makeup SPF 15 by is a Otc medication manufactured, distributed, or labeled by Almay, Inc., REVLON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Octinoxate: 3.5%

Titanium Dioxide 4.3%

Purpose

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 notuse 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 a 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
Use a water resistant sunscreen if swimming or sweating
Reapply 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 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),

Principal Display Panel

Almay 

Age Essentials Makeup

Broad Spectrum

SPF 15

1.0 fL. OZ/30 mL

INGREDIENTS AND APPEARANCE

ALMAY AGE ESSENTIALS MAKEUP SPF 15 
octinoxate, titanium dioxide make-up liquid

Product 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)