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

  • NDC Code(s): 10967-652-11
  • Packager: Revlon Consumer Products Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 1, 2019

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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