REVLON AGE DEFYING 3X Foundation

[Pages:5]REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15- octinoxate, titanium dioxide make-up liquid Revlon Cons umer Products Corp 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. ---------REVLON AGE DEFYING 3X Foundation

Active Ingredients : Octinoxate: 3.5% Titanium Dioxide 4.3%

Purpos e

Sunscreen

Us es : ?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 Meas ures 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, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINA, CAPRYLYL GLYCOL, PHENOXYETHANOL, SILICA, NIACINAMIDE, LAURETH-7, SODIUM CHLORIDE, POLYGLYCERYL-3 DIISOSTEARATE, PULLULAN, DIMETHICONE CROSSPOLYMER, METHICONE, XANTHAN GUM, POTASSIUM SORBATE, TRIETHOXYCAPRYLYLSILANE, SORBITOL, TREHALOSE, SODIUM ASCORBYL PHOSPHATE, TOCOPHERYL ACETATE, CALCIUM ALUMINUM BOROSILICATE, C12-15 ALKYL BENZOATE, TETRASODIUM EDTA, GLYCYRRHETINIC ACID, ACETYL HYDROXYPROLINE, ACACIA SENEGAL GUM, TOCOPHEROL, SODIUM CITRATE, DIPROPYLENE GLYCOL, METHYL ACETYLGLYCYRRHETINOYL HYDROXYPROLINATE, LINOLEIC ACID, LECITHIN, SODIUM HYALURONATE, PHYTOSTERYL CANOLA GLYCERIDES, HYDROLYZED GLYCOSAMINOGLYCANS, PALMITIC ACID, OLEIC ACID, TRIOLEIN, STEARIC ACID, PALMITOYL TRIPEPTIDE-5, ACETYL HEXAPEPTIDE-8

Principal Dis play Panel

REVLON

Age Defying Firming + Lifting Makeup

Broad Spectrum

SPF 15

1.0 fL. OZ/30 mL

REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15

octinoxate, titanium dioxide make-up liquid

Product Information

Prod uct T yp e Route of Ad minis tration

HUMAN O TC DRUG TO PICAL

Ite m Cod e (S ource )

NDC:10 9 6 7-6 21

Active Ing redient/Active Moiety

Ing redient Name

O CTINO XATE (UNII: 4Y5P7MUD51) (O CTINO XATE - UNII:4Y5P7MUD51) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIO XIDE - UNII:15FIX9 V2JP)

Basis of Strength

O CTINO XATE TITANIUM DIO XIDE

Stre ng th

3.5 mg in 1 mL 4.3 mg in 1 mL

Inactive Ing redients

Ing redient Name

WATER (UNII: 0 59 Q F0 KO 0 R) DIMETHICO NE (UNII: 9 2RU3N3Y1O ) PHENYL TRIMETHICO NE (UNII: DR0 K5NO J4R) METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT) LAURETH-7 (UNII: Z9 5S6 G8 20 1) ALUMINUM O XIDE (UNII: LMI26 O 6 9 33) .ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 ) XANTHAN GUM (UNII: TTV12P4NEE) NIACINAMIDE (UNII: 25X51I8 RD4) TRIMETHYLSILO XYSILICATE ( M/Q 0 .8 -1.0 ) (UNII: 25LXE46 4L2) CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R) PEG-9 PO LYDIMETHYLSILO XYETHYL DIMETHICO NE (UNII: TYP8 1E471F) BO RO N NITRIDE (UNII: 2U4T6 0 A6 YD) DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L) PHENO XYETHANO L (UNII: HIE49 2ZZ3T) SO DIUM CHLO RIDE (UNII: 451W47IQ 8 X) PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4) TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E) SO DIUM ASCO RBYL PHO SPHATE (UNII: 8 36 SJG51DR) TO CO PHERO L (UNII: R0 ZB2556 P8 ) LINO LEIC ACID (UNII: 9 KJL21T0 Q J) LECITHIN, SO YBEAN (UNII: 1DI56 Q DM6 2) PALMITIC ACID (UNII: 2V16 EO 9 5H1) O LEIC ACID (UNII: 2UMI9 U37CP) STEARIC ACID (UNII: 4ELV7Z6 5AP) SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) EDETATE SO DIUM (UNII: MP1J8 420 LU) ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ ) GLYCERIN (UNII: PDC6 A3C0 O X) CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U) PO LYGLYCERYL-3 DIISO STEARATE (UNII: 46 P231IQ V8 ) PULLULAN (UNII: 8 ZQ 0 AYU1TT) SO RBITO L (UNII: 50 6 T6 0 A25R)

Stre ng th

TREHALO SE (UNII: B8 WCK70 T7I) CALCIUM ALUMINUM BO RO SILICATE (UNII: 3JRB8 A35M0 ) ENO XO LO NE (UNII: P540 XA0 9 DR) O XACEPRO L (UNII: Q 0 XV76 B9 6 L) ACACIA (UNII: 5C540 3N26 O ) DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 ) HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH) HYDRO LYZED GLYCO SAMINO GLYCANS ( BO VINE; 50 0 0 0 MW) (UNII: 9 9 738 5V0 VV) PALMITO YL TRIPEPTIDE-5 (UNII: 2A39 16 MQ HO ) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)

Packag ing

# Item Code

Packag e Descriptio n

1

NDC:10 9 6 7-6 2101

30 mL in 1 BO TTLE, GLASS; Type 0 : No t a Co mbina tio n Pro duc t

Marketing Start Date

0 9 /30 /20 13

Marketing End Date

Marketing Information

Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation O TC mo no gra ph fina l pa rt352

Marke ting S tart Date 0 9 /30 /20 13

Marke ting End Date

Labeler - Revlon Cons umer Products Corp (788820165)

Establishment

Na me REVLO N, INC.

Addre ss

ID/FEI 8 0 9 725570

Revised: 6/2018

Bus ine s s Op e rations ma nufa c ture (10 9 6 7-6 21)

Revlon Consumer Products Corp

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