REVLON NEW COMPLEXION ONE-STEP PERFECT MAKE-UP- titanium dioxide make-up paste

Revlon New Complexion One-Step Perfect Make-Up by

Drug Labeling and Warnings

Revlon New Complexion One-Step Perfect Make-Up by is a Otc medication manufactured, distributed, or labeled by Revlon Consumer Products Corp, REVLON, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide 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,ISOPROPYL,ISOSTEARATE,TALC,SILICA,NEOPENTYL,GLYCOL,DIETHYLHEXANOATE,TRIBEHENIN,ISOSTEARYL,BEHENATE,NYLON-12,BORON,NITRIDE,LAUROYL,LYSINE,TRIDECYL,TRIMELLITATE,MYRISTYL,MYRISTATE,CANDELILLA,CERA,((EUPHORBIA,CERIFERA,(CANDELILLA)WAX),CIRE,DE,CANDELILLA,POLYGLYCERYL-4,ISOSTEARATE,SORBITAN,TRIOLEATE,PENTAHYDROSQUALENE,LAURYL,PEG/PPG-18/18,METHICONE,SACCHAROMYCES,ZINC,FERMENT,SACCHAROMYCES,COPPER,FERMENT,SACCHAROMYCES,MANGANESE,FERMENT,SACCHAROMYCES,IRON,FERMENT,SACCHAROMYCES,SILICON,FERMENT,SACCHAROMYCES,POTASSIUM,FERMENT,CYCLOMETHICONE,SOY,AMINO,ACIDS,CERA,CARNAUBA,((COPERNICIA,CERIFERA,(CARNAUBA),WAX),CIRE,DE,CARNAUBA,TRIMETHYLSILOXYSILICATE,POLYETHYLENE,ETHYLENE/METHACRYLATE,COPOLYMER,LECITHIN,ISOPROPYL,TITANIUM,TRIISOSTEARATE,ALUMINA,BARIUM,SULFATE,DEHYDROACETIC,ACID,METHYLPARABEN,ETHYLPARABEN,PROPYLPARABEN,PHENOXYETHANOL,BHT

May Contain: Mica, Titanium Dioxide (Ci 77891), Iron Oxides (CI 77491, 77492, 77499)

Principal Display Panel:

​REVLON

New Complexion SPF 15 Makeup

SPF 15

INGREDIENTS AND APPEARANCE

REVLON NEW COMPLEXION ONE-STEP PERFECT MAKE-UP 
titanium dioxide make-up paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-606
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
TALC (UNII: 7SEV7J4R1U)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
ISOSTEARYL BEHENATE (UNII: NA95U012OW)
BORON NITRIDE (UNII: 2U4T60A6YD)
LAUROYL LYSINE (UNII: 113171Q70B)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
CANDELILLA WAX (UNII: WL0328HX19)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)
2,10,15,19,23-PENTAHYDROSQUALENE (UNII: 6IWZ426YD6)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
AMINO ACIDS, SOY (UNII: NWB9514AZM)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-606-35	9.9 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2014

Labeler - Revlon Consumer Products Corp (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
REVLON, INC.		809725570	manufacture(10967-606)