LA ROCHE POSAY REDERMIC C UV SUNSCREEN (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]

LA ROCHE POSAY REDERMIC C UV SUNSCREEN (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-728-01
Set ID 19bcc85b-1637-411e-a6f7-d4f9e776563a
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3%

    Octisalate 5%

    Octocrylene 7%

  • Directions

    For sunscreen use:

    - apply generously 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

  • 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.

  • 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 he sun

  • Purpose

    Sunscreen

  • Other information

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

    - store at 20 - 25 C (68 to 77 F)

  • Questions or comments?

    1-888-LRP-LABO 1-888-577-5226

    Monday - Friday (9 a.m. - 5 p.m. (EST)

  • Inactive ingredients

    water, isononyl isononanoate, glycerin, mannose, ascorbic acid, dimethicone, diisopropyl sebacate, silica, sucrose tristearate, pentylene glycol, potassium hydroxide, polysorbate 61, PEG-12 dimethicone, madecassoside, dimethiconol, sodium stearoyl glutamate, ammonium polyacryloyldimethyl taurate, disodium EDTA, hydrolyzed hyaluronic acid, caprylyl glycol, acetyl dipeptide-1 cetyl ester, xanthan gum, fragrance

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY REDERMIC C UV SUNSCREEN 
    avobenzone, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-728
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNOSE, D- (UNII: PHA4727WTP)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE TRISTEARATE (UNII: 71I93STU5M)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POLYSORBATE 61 (UNII: X9E1MY2JQG)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-728-011 in 1 CARTON12/01/2012
    140 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 finalpart35212/01/2012
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-728)

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