REVLON YOUTH FX- zinc oxide, titanium dioxide make-up liquid

Revlon Youth FX by

Drug Labeling and Warnings

Revlon Youth FX 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 4.3%

Zinc Oxide 2.8

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, Cyclopentasiloxane, Aqua (Water (Eau)), PEG/PPG-19/19 Dimethicone, C13-16 Isoparaffin, Trimethylsiloxysilicate, Isohexadecane, Dimethicone Crosspolymer, Stearyl Heptanoate, Boron Nitride, Tribehenin, Stearyl Caprylate, C10-13 Isoparaffin, Maris Sal ((Sea Salt) Sel Marin), Tocopherol, Niacinamide, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Sodium Carrageenan, Saccharide Isomerate, Glycerin, Trisiloxane, Alumina, Methicone, Triethoxycaprylylsilane, Polymethylsilsesquioxane, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, HDI/Trimethylol Hexyllactone Crosspolymer, Sorbitan Sesquioleate, Tetrasodium EDTA, Phenoxyethanol, 1,2-Hexanediol, Caprylyl Glycol

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

Principal Display Panel:

​REVLON

Revlon Youth FX Fill + Blur Foundation

1.0 fL. OZ/30 mL

INGREDIENTS AND APPEARANCE

REVLON YOUTH FX 
zinc oxide, titanium dioxide make-up liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-639
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.8 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.3 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
GLYCERIN (UNII: PDC6A3C0OX)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)
ISOHEXADECANE (UNII: 918X1OUF1E)
STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)
BORON NITRIDE (UNII: 2U4T60A6YD)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SEA SALT (UNII: 87GE52P74G)
TOCOPHEROL (UNII: R0ZB2556P8)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
TRISILOXANE (UNII: 9G1ZW13R0G)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
EDETATE SODIUM (UNII: MP1J8420LU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-639-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	09/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/19/2019

Labeler - Revlon Consumer Products Corp (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
REVLON, INC.		809725570	manufacture(10967-639)