Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERIANE DOUBLE REPAIR UV BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

  • NDC Code(s): 69625-583-01, 69625-583-02, 69625-583-03, 69625-583-04, view more
    69625-583-05, 69625-583-06
  • Packager: Cosmetique Active Production
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

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  • Active ingredients

    Avobenzone 3%

    Homosalate 5%

    Octisalate 5%

    Octocrylene 7%

  • 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:
    ● shake well

    ● 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, glycerin, silica, dimethicone, niacinamide, PEG-100 stearate, glyceryl stearate, stearic acid, allantoin, ceramide 3, dimethicone/vinyl dimethicone crosspolymer, sodium hydroxide, myristic acid, myristyl alcohol, palmitic acid, ammonium polyacryloyldimethyl taurate, disodium EDTA, capryloyl glycine, caprylyl glycol, citric acid, xanthan gum, t-butyl alcohol, cetyl alcohol, tocopherol

  • Questions or comments?

    1-888-LRP-LABO 1-888-577-5226

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

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERIANE DOUBLE REPAIR UV BROAD SPECTRUM SPF 30 SUNSCREEN 
    avobenzone, homosalate, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69625-583
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69625-583-011 in 1 CARTON12/21/201612/21/2016
    175 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69625-583-022 mL in 1 PACKET; Type 0: Not a Combination Product12/21/2016
    3NDC:69625-583-033 mL in 1 TUBE; Type 0: Not a Combination Product12/21/2016
    4NDC:69625-583-041 in 1 CARTON12/12/2022
    4100 mL in 1 TUBE; Type 0: Not a Combination Product
    5NDC:69625-583-051 in 1 CARTON12/21/201606/01/2026
    575 mL in 1 TUBE; Type 0: Not a Combination Product
    6NDC:69625-583-061 in 1 CARTON01/01/2024
    640 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/21/2016
    Labeler - Cosmetique Active Production (282658798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(69625-583) , pack(69625-583)
    Establishment
    NameAddressID/FEIBusiness Operations
    Socoplan276221405pack(69625-583)
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