Label: PROTECTYL SOLEIL MOISTURIZING SUNSCREEN LOTION HIGH PROTECTION SPF 30- titanium dioxide, octinoxate and octocrylene lotion

  • 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 April 28, 2011

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  • ACTIVE INGREDIENT

    Actives ingredients
    Octinoxate 7.5%
    Octocrylene 7.0%
    Titanium dioxide 8.4%

  • PURPOSE

    Purpose
    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Uses
    Helps prevent sunburn. Higher SPF gives more sunburn protection.
  • WARNINGS

    Warnings:
    For external use only.     When using this product, keep out of eyes. Rinse with water to remove.
    Stop use and ask a doctor if rash and irritation develops and lasts.

  • DOSAGE & ADMINISTRATION

    Directions:
    Apply liberally 15 to 30 minutes before sun exposure and as needed. Reapply as needed
    or after towel drying, swimming, perspiring heavily or washing.

  • ASK DOCTOR

    Children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients:
    ACER SACCHARINUM (SUGAR MAPLE) EXTRACT - ALLANTOIN - ALUMINA - ALUMINUM STEARATE - BUTYLENE GLYCOL - BUTYLPARABEN - C12-15 ALKYL BENZOATE - CYCLOHEXASILOXANE - CYCLOPENTASILOXANE - DIMETHICONE - DIMETHICONE CROSSPOLYMER - ETHYLPARABEN - FRAGRANCE (PARFUM) - GLYCERIN - CLYCERYL STEARATE - HYDROGENATED DIMER DILINOLEYL / DIMETHYLCARBONATE COPOLYMER - HUDROXYETHYLCELLULOSE - MANGIFERIN - METHYLPARABEN - METHYLPROPANEDIOL - PEG-100 STEARATE - PHENOXYETHANOL - POLYHYDROXYSTEARIC ACID - PROPYLENE GLYCOL - PROPYLPARABEN - SILICA - SORBITAN STEARATE - STEARETH-100 - TETRASODIUM EDTA - TOCOPHERYL ACETATE - VP/EICOSENE COPOLYMER - WATER (AQUA) - XANTHAN GUM

  • PRINCIPAL DISPLAY PANEL

    Protectyl Soleil

    Moisturizing Sunscreen Lotion
    High Protection SPF30

    150 ml     5 fl.oz.


    Front label

    Back label



  • INGREDIENTS AND APPEARANCE
    PROTECTYL SOLEIL MOISTURIZING SUNSCREEN LOTION HIGH PROTECTION SPF 30 
    titanium dioxide, octinoxate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63505-156
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.0 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)  
    MANGIFERIN (UNII: 1M84LD0UMD)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63505-156-08150 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/01/2007
    Labeler - Yves Rocher North America Inc (201908311)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher347509127manufacture
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