REVLON COLORSTAY PREO AND PROTECT PRIMER- titanium dioxide, zinc oxide, octinoxate primer liquid 
Revlon Consumer Products Corp

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.

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Revlon Colorstay Prep & Protect Primer / Base

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

Colorstay Prep & Protect Primer/ BaseREVLON

Colorstay Prep & Protect Primer / Base

REVLON COLORSTAY PREO AND PROTECT PRIMER 
titanium dioxide, zinc oxide, octinoxate primer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-652
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10967-652-1126.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2019
Labeler - Revlon Consumer Products Corp (788820165)
Establishment
NameAddressID/FEIBusiness Operations
Revlon, INC.809725570manufacture(10967-652)

Revised: 1/2019
Document Id: 8eebf23e-7fcf-dfc0-e053-2995a90ae322
Set id: 8eebf23e-7fce-dfc0-e053-2995a90ae322
Version: 1
Effective Time: 20190101
 
Revlon Consumer Products Corp