UV BASE SPF 50 (AVOBENZONE, OCTINOXATE, OCTISALATE) CREAM [LUXE ART BEAUTE SAS]

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UV BASE SPF 50 (AVOBENZONE, OCTINOXATE, OCTISALATE) CREAM [LUXE ART BEAUTE SAS]
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NDC 69879-120-30
Set ID ab02adb4-3997-40cf-9c6d-ea5aa525cb6b
Category HUMAN OTC DRUG LABEL
Packager LUXE ART BEAUTE SAS
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active ingredients

    Avobenzone 3%

    Octinoxate 6.8%

    Octisalate 4.5%

    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

    • Apply liberally and evenly 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Usa 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, BUTYLENE GLYCOL, ISOTRIDECYL ISONONANOATE, DIMETHICONE, PENTYLENE GLYCOL, DEXTRIN PALMITATE, PHENOXYETHANOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PEG-60 GLYCERYL ISOSTEARATE, FRAGRANCE, CARBOMER, TOCOPHEROL, SODIUM HYDROXIDE, PALMITIC ACID, DISODIUM EDTA, BHT.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    UV BASE SPF 50 
    avobenzone, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69879-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE68 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69879-120-301 in 1 CASE03/26/2018
    130 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 finalpart35203/26/2018
    Labeler - LUXE ART BEAUTE SAS (378611552)
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