GARNIER SKIN RENEW MIRACLE SKIN PERFECTOR BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [L'OREAL USA PRODUCTS INC]

GARNIER SKIN RENEW MIRACLE SKIN PERFECTOR BB (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [L'OREAL USA PRODUCTS INC]
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NDC 49967-779-01
Set ID 5374a4d5-7805-4808-bb2a-f272dbbe1bb2
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Octinoxate 4%

    Titanium dioxide 2.1%

  • Purpose

    Sunscreen

  • Uses

    - helps prevent sunburn

    - if used as directed with other sun protection measures (see Directions), 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 eyes. Rinse with water to remove.

  • Stop use and ask a doctor if

    rash occurs

  • Keep out of reach of children.

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

  • Directions

    For sunscreen use:

    ● apply liberally 15 minutes before sun exposure

    ● reapply at least every 2 hours

    ● use a water resistant sunscreen if swimming or sweating

    ● 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 10 a.m. – 2 p.m.

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

    ● children under 6 months of age: Ask a doctor

  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    water, isononyl isononanoate, isohexadecane, glycerin, alcohol denat., PEG-20 methyl glucose sesquistearate, methyl glucose sesquistearate, cetyl palmitate, nylon-12, cyclohexasiloxane, propylene glycol, hydrogenated polyisobutene, stearyl alcohol, magnesium aluminum silicate, phenoxyethanol, caprylyl glycol, lithium magnesiuim sodium silicate, disodium EDTA, linalool, benzyl salicylate, limonene, caffeine, ascorbyl glucoside, benzyl alcohol, geraniol, cellulose acetate butyrate, polyphosphorylcholine glycol acrylate, citral, ammonium polyacryloyldimethyl taurate, polyvinyl alcohol, sodium chloride, butylene glycol, sodium hyaluronate, fragrance; may contain: titanium dioxide, iron oxides

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    GARNIER SKIN RENEW MIRACLE SKIN PERFECTOR BB 
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-779
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate40 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE21 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-779-011 in 1 CARTON08/01/2011
    175 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2011
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA Products Inc624244349manufacture(49967-779)

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