REVLON COLORSTAY PREO AND PROTECT PRIMER- titanium dioxide, zinc oxide, octinoxate primer liquid

Revlon Colorstay Preo and Protect Primer by

Drug Labeling and Warnings

Revlon Colorstay Preo and Protect Primer 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 3.6%

Zinc Oxide 9.0%

Octinoxate 7.5%

Purpose

Sunscreen

Warnings

For external use only.

Do not use 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 rash occurs.

Keep out of reach of children.

If swollowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure.

Repply at least every 2 hours.

Use a water resistant sunscreen when swimming or sweating

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly us sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun proection measures including:

- limit time in the sun, especially from 10a.m - 2p.m.

- wear long -sleeved shirts, pants, hats and sunglasses.

- children under 6 months: Ask a doctor

Inactive Ingredients

CYCLOPENTASILOXANE; AQUA/WATER/EAU; ZINC OXIDE ; ETHYLHEXYL METHOXYCINNAMATE; TRIMETHYLSILOXYSILICATE; GLYCERIN; TITANIUM DIOXIDE; PEG-10 DIMETHICONE; PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE; DIMETHICONE; POLYMETHYLSILSESQUIOXANE; HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER]; HEXYL LAURATE; POLYGLYCERYL-4 ISOSTEARATE; PERLITE; DIMETHICONE/PEG-10/15 CROSSPOLYMER; PHENOXYETHANOL; XANTHAN GUM; MAGNESIUM SULFATE; STEARIC ACID; CAPRYLYL GLYCOL; 1,2-HEXANEDIOL; ALUMINA; CITRULLUS LANATUS (WATERMELON) FRUIT EXTRACT]; LENS ESCULENTA (LENTIL) FRUIT EXTRACT; POLYSILICONE-11; PYRUS MALUS (APPLE) FRUIT EXTRACT; IRON OXIDES (CI 77499); TOCOPHERYL ACETATE; SODIUM LACTATE; SODIUM PCA; TETRASODIUM EDTA; ETHYLHEXYL PALMITATE; BUTYLENE GLYCOL; SALICYLIC ACID; SILICA DIMETHYL SILYLATE

Package label for Revlon Colorstay Prep & Protect Primer/Base

Principal Display Panel

REVLON

Colorstay Prep & Protect Primer / Base

INGREDIENTS AND APPEARANCE

REVLON COLORSTAY PREO AND PROTECT PRIMER 
titanium dioxide, zinc oxide, octinoxate primer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-652
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PERLITE (UNII: 0SG101ZGK9)
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM LACTATE (UNII: TU7HW0W0QT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
WATERMELON (UNII: 231473QB6R)
APPLE (UNII: B423VGH5S9)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-652-11	26.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2019

Labeler - Revlon Consumer Products Corp (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Revlon, INC.		809725570	manufacture(10967-652)