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

Revlon Nearly Naked Makeup by

Drug Labeling and Warnings

Revlon Nearly Naked Makeup 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:

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

INGREDIENTS AND APPEARANCE

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

Product 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)