REVLON NEARLY NAKED MAKEUP- octinoxate, titanium dioxide make-up liquid 
Revlon Consumer 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.

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Revlon Nearly Naked Makeup

Active Ingredients:

Octinoxate: 3.5%

Titanium Dioxide 9.5%

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, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYLSILOXYSILICATE, PHENYL TRIMETHICONE, BORON NITRIDE, DISTEARDIMONIUM HECTORITE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINA, SILICA, CAPRYLYL GLYCOL, PHENOXYETHANOL, LAURETH-7, SODIUM CHLORIDE, DIMETHICONE CROSSPOLYMER, METHICONE, XANTHAN GUM, POTASSIUM SORBATE, TRIETHOXYCAPRYLYLSILANE, SODIUM ASCORBYL PHOSPHATE, NIACINAMIDE, HYDROLYZED OAT FLOUR, TETRASODIUM EDTA, TOCOPHERYL ACETATE, C12-15 ALKYL BENZOATE, TOCOPHEROL, SODIUM CITRATE, DIPROPYLENE GLYCOL, SODIUM LAUROYL LACTYLATE, CAMELLIA SINENSIS LEAF EXTRACT, LINOLEIC ACID, LECITHIN, METHOXY AMODIMETHICONE/SILSESQUIOXANE COPOLYMER, PHYTOSTERYL CANOLA GLYCERIDES, PALMITIC ACID, OLEIC ACID, CERAMIDE 3, STEARIC ACID, TRIOLEIN, HYDROGENATED JOJOBA OIL, PHYTOSPHINGOSINE, CERAMIDE 6 II, CHOLESTEROL, CARBOMER, CERAMIDE 1

Principal Display Panel

REVLON

Nearly Naked Makeup

Broad Spectrum

SPF 20

1.0 fL. OZ/30 mL

image description

REVLON NEARLY NAKED MAKEUP 
octinoxate, titanium dioxide make-up liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-622
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 DIOXIDE1.9 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)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
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)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
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)  
OATMEAL (UNII: 8PI54V663Y)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERYL TRIOLEATE (UNII: O05EC62663)  
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10967-622-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/19/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/19/2012
Labeler - Revlon Consumer Products Corp (788820165)
Establishment
NameAddressID/FEIBusiness Operations
REVLON, INC.809725570manufacture(10967-622)

Revised: 11/2016
Document Id: 42748194-73f1-5470-e054-00144ff8d46c
Set id: a8e84e40-1c8c-41c8-9d3c-d632e7715564
Version: 1
Effective Time: 20161129
 
Revlon Consumer Products Corp