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

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.

----------

Almay Age Essentials Makeup SPF 15

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

image description

ALMAY AGE ESSENTIALS MAKEUP SPF 15 
octinoxate, titanium dioxide make-up liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0707
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0311-0707-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/18/2016
Labeler - Almay, Inc. (064988652)
Establishment
NameAddressID/FEIBusiness Operations
REVLON, INC.809725570manufacture(0311-0707)

Revised: 12/2016
Document Id: 42b3d1ef-3ce4-0b87-e054-00144ff8d46c
Set id: 5f7d9231-84c1-44a0-9140-a2792e9be73c
Version: 2
Effective Time: 20161202
 
Almay, Inc.