Label: 10 ARMANI PRIMA CONTROL GLOW MOISTURIZER SBS SPF 35- octinoxate, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2023

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  • Drug Facts

  • Active ingredients 

    Octinoxate 5%

    Titanium dioxide  1.9%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see  decreases the risk of skin cancer and early skin aging caused by the sun Directions), 
  • Warnings

    For external use only

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

    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:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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: Sun Protection Measures. 
    • 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, 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

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    10 ARMANI PRIMA CONTROL GLOW MOISTURIZER SBS SPF 35 
    octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70581-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE19 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70581-019-001 in 1 BOX01/01/2018
    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 DrugM02001/01/2018
    Labeler - BPS 60 (272259304)
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