MAESTRO UV SKIN DEFENSE PRIMER SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, OCTINOXATE, OCTISALATE) CREAM [LABORATOIRES BIOCOSM SARL]

MAESTRO UV SKIN DEFENSE PRIMER SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, OCTINOXATE, OCTISALATE) CREAM [LABORATOIRES BIOCOSM SARL]
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NDC 70581-001-30
Set ID 8f01e02a-e7a9-427d-ba38-fd3aa2e67707
Category HUMAN OTC DRUG LABEL
Packager Laboratoires Biocosm SARL
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active ingredients

    Avobenzone 3%
    Octinoxate 7.5%
    Octisalate 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

    For sunscreen use:

    • shake well before use
    • apply liberally 15 minutes before sun exposure
    • reaply 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
  • Inacitve ingredients

    c12-15 alkyl benzoate, water, butylene glycol, methyl methacrylate crosspolymer polymethylsilsesquioxane, vinyl dimethicone/ methicone silsesquioxane crosspolymer, isononyl isononanoate, glycerin, dicaprylyl carbonate, pentylene glycol, polyglyceryl-6 polyricinoleate, fragrance, tocopherol, sodium chloride, phenoxyethanol, stearyl glycyrrhetinate, polyglyceryl-2 isostearate, limonene, benzyl salicylate, benzyl alcohol, linalool, tetrasodium EDTA, butylphenyl methylpropional, hexyl cinnamal

  • Package Labeling:

    LabelMaestroFront

  • INGREDIENTS AND APPEARANCE
    MAESTRO UV SKIN DEFENSE PRIMER SUNSCREEN BROAD SPECTRUM SPF 50 
    avobenzone, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70581-001
    Route of AdministrationTOPICAL, TOPICAL
    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) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    .ALPHA.-HEXYLCINNAMALDEHYDE, (2E)- (UNII: E9947QRR9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70581-001-301 in 1 BOX04/06/2016
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/06/2016
    Labeler - Laboratoires Biocosm SARL (288479491)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Biocosm SARL288479491pack(70581-001)

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