ALMAY AGE ESSENTIALS CONCEALER SPF 20- octinoxate zinc oxide 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.

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Almay Age Essentials Concealer SPF 20

Active Ingredients:

Octinoxate: 7.5%

Zinc Oxide 2.4%

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

Dimethicone, Polyethylene, Neopentyl Glycol Diheptanoate, Trimethylsiloxysilicate, Polyisobutene, Caprylyl Methicone, Phenyl Trimethicone, Boron Nitride, Ozokerite, Sorbitan Trioleate, Kaolin, Isodecyl Neopentanoate, Tocopheryl Acetate, Hyaluronic Acid, Atelocollagen, Tocopherol, Soluble Collagen, Tripeptide-29, Sodium Hyaluronate, Trisiloxane, Isostearyl Behenate, Triethoxycaprylylsilane, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Disteardimonium Hectorite, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Isopropyl Titanium Triisostearate, Triethyl Citrate, Phospholipids, Ethylhexyl Palmitate, Sodium Chondroitin Sulfate, Silica Dimethyl Silylate, Sorbic Acid

Principal Display Panel

Almay 

Age Essentials Concealer

SPF 20

0.13 oz/ 3.7g

image description

ALMAY AGE ESSENTIALS CONCEALER SPF 20 
octinoxate zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0708
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
KAOLIN (UNII: 24H4NWX5CO)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONIC ACID (UNII: S270N0TRQY)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
ISOSTEARYL BEHENATE (UNII: NA95U012OW)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
SORBIC ACID (UNII: X045WJ989B)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CERESIN (UNII: Q1LS2UJO3A)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0311-0708-133.8 mL in 1 CONTAINER; Type 0: Not a Combination Product04/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/16/2016
Labeler - Almay, Inc. (064988652)
Establishment
NameAddressID/FEIBusiness Operations
REVLON, INC.809725570manufacture(0311-0708)

Revised: 12/2016
Document Id: 437c7408-d5db-1e1e-e054-00144ff88e88
Set id: 8b4a5b57-8f19-4b71-a9c7-f65e5fe4df83
Version: 2
Effective Time: 20161212
 
Almay, Inc.