REVLON COLORSTAY LIGHT COVER FOUNDATION- homosalate, octisalate, octocrylene, titanium dioxide,zinc oxide emulsion

Revlon Colorstay Light Cover Foundation by

Drug Labeling and Warnings

Revlon Colorstay Light Cover Foundation by is a Otc medication manufactured, distributed, or labeled by Revlon, Revlon INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

Helps prevent Sunburn

If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only.

Do not use on damaged or broken skin

When using this product keep out of the eyes. Rinse with water to remove.

Stop use and ask doctor is rash occurs.

KEEP OUT OF REACH OF CHILDREN

If product is swallowed, get medical help or contact Poison Control Center right away.

Active Ingredients

Homosalate 6.00%

Octisalate 3.00%

Octocrylene 2.40%

Titanium Dioxide 6.97%

Zinc Oxide 4.99%

Directions

Apply liberally 15 minutes before sun exposure

Use water resistant sunscreen if swimming or sweating

Repply 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 10am-2pm, wear long-sleeved shirts, pants, hats and sunglasses.

INACTIVE INGREDIENT

Isododecane, Aqua/Water/Eau, Trimethylsiloxysilicate, Titanium Dioxide, Homosalate,
Zinc Oxide [nano], Dimethicone, Cyclopentasiloxane, Glycerin, Propanediol, Ethylhexyl Salicylate,
PEG-10 Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Octocrylene, Niacinamide,
PEG/PPG-18/18 Dimethicone, Alumina, Methyl Methacrylate Crosspolymer, Punica Granatum Sterols,
Phenyl Trimethicone, 1,2-Hexanediol, Alcohol Denat., Caffeine, Caprylyl Glycol, Dimethicone
Crosspolymer, Dimethiconol, Disteardimonium Hectorite, Hydrogen Dimethicone, Isoceteth-10,
Lecithin, Magnesium Sulfate, Methicone, Mica, Polyglyceryl-3 Diisostearate, Polysilicone-11,
Propylene Carbonate, Silica, Silica silylate, Tetrasodium EDTA, Tocopheryl Acetate,
Triethoxycaprylylsilane, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891).

DOSAGE & ADMINISTRATION

As Needed

INDICATIONS & USAGE

• Helps prevent sunburn

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVLON COLORSTAY LIGHT COVER FOUNDATION 
homosalate, octisalate, octocrylene, titanium dioxide,zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-663
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.97 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.99 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYL METHACRYLATE (UNII: 196OC77688)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PROPANEDIOL (UNII: 5965N8W85T)
NIACINAMIDE (UNII: 25X51I8RD4)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CAFFEINE (UNII: 3G6A5W338E)
DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V)
METHICONE (20 CST) (UNII: 6777U11MKT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
DIMETHICONE 100 (UNII: RO266O364U)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALCOHOL (UNII: 3K9958V90M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHICONE 1000 (UNII: MCU2324216)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ISOCETETH-10 (UNII: 1K92T9919H)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-663-01	1 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2020

Labeler - Revlon (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Revlon INC.		809725570	manufacture(10967-663)