Label: REVLON NEARLY NAKED MAKEUP- octinoxate, titanium dioxide make-up liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 10967-622-01 - Packager: Revlon Consumer Products Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 29, 2016
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- Active Ingredients:
- Purpose
- Uses:
- Warnings:
- Directions
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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
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INGREDIENTS AND APPEARANCE
REVLON NEARLY NAKED MAKEUP
octinoxate, titanium dioxide make-up liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-622 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-622-01 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/19/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/19/2012 Labeler - Revlon Consumer Products Corp (788820165) Establishment Name Address ID/FEI Business Operations REVLON, INC. 809725570 manufacture(10967-622)