10 ARMANI PRIMA CONTROL GLOW MOISTURIZER SBS SPF 35 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATOIRES BIOCOSM SARL]

10 ARMANI PRIMA CONTROL GLOW MOISTURIZER SBS SPF 35 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [LABORATOIRES BIOCOSM SARL]
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NDC 70581-019-00
Set ID 9dc66fbf-bc66-4c60-9675-05b193da91da
Category HUMAN OTC DRUG LABEL
Packager Laboratoires Biocosm SARL
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts
  • Active ingredients 

    Octinoxate 5%

    Titanium dioxide  1.9%

    Purpose

    Sunscreen

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  • 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
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  • Warnings

    For external use only

    Flammable until dry. Do not use near fire, flame or heat.

    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.

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  • 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
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  • Other information

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

    water, dimethicone, glycerin, alcohol denat., isododecane, PEG-10 dimethicone, dipropylene glycol, pentylene glycol, disteardimonium hectorite, betaine, talc, diisostearyl malate, fragrance, tocopheryl acetate, macadamia ternifolia seed oil, phenoxyethanol, adenosine, magnesium sulfate, magnesium aspartate, ethylhexyl hydroxystearate, ethyl menthane carboxamide, silica, dimethiconol, dimethicone/vinyl dimethoicone crosspolymer, simmondsia chinensis (jojoba) seed oil, limonene, zinc gluconate, linalool, benzyl alcohol, copper gluconate, coriandrum sativum (coriander) fruit oil, moringa pterygosperma seed extract, passiflora edulis seed oil, disodium stearoyl glutamate, methicone, prunus armeniaca (apricot) kernel oil, aluminum starch octenylsuccinate, alumina, aluminum hydroxide; may contain: red 28 lake, red 7, iron oxides, bismuth oxychloride, titanium dioxide

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    10 ARMANI PRIMA CONTROL GLOW MOISTURIZER SBS SPF 35 
    octinoxate, titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70581-019
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 19 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BETAINE (UNII: 3SCV180C9W)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ADENOSINE (UNII: K72T3FS567)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    MORINGA OLEIFERA SEED (UNII: TIX5482832)  
    PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70581-019-00 1 in 1 BOX 01/01/2018
    1 30 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/01/2018
    Labeler - Laboratoires Biocosm SARL (288479491)
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