FORME COSMETICS DELICIOUS LIP BALM SPF 12 (TITANIUM DIOXIDE, OCTINOXATE, AVOBENZONE) LIPSTICK [CHROMAVIS SPA]

FORME COSMETICS DELICIOUS LIP BALM SPF 12 (TITANIUM DIOXIDE, OCTINOXATE, AVOBENZONE) LIPSTICK [CHROMAVIS SPA]
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NDC 49825-070-01
Set ID bdc10f9f-7e90-4794-b813-773f483a655c
Category HUMAN OTC DRUG LABEL
Packager CHROMAVIS SPA
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Titanium Dioxide 1.29%, Avobenzone 1.50%, Octinoxate 6.00%
  • PURPOSE

    Protect and SPF12

  • WARNINGS

    Stop use if rash occurs. As described in the Package Label-principal display area 
  • Other Ingredients

    Hydrogenated polyisobutene, Cera microcristallina (Microcrystalline wax), Caprylic/Capric Triglyceride, Tridecyl Trimellitate, Polybutene, Polyethylene, Ricinus Communis oil (ricinus communis (castor) seed oil), Diisostearyl Malate, Butyrospermum Parkii butter (Butyrospermum parkii (shea Butter), Ethylhexyl palmitate,Oryzanol, Tocopheryl acetate,Tribehenin, Prunus armeniaca kernel oil (prunus armeniaca (apricot) kernel oil), Dimethicone, Cyclomethicone, Sorbitan isostearate, Ethylene/VA Copolymer, Isododecane, BHT, Lactic acid, Palmitoyl Oligopeptide, Propylparaben, Methylparaben, Aroma (Flavor)

    May Contain: Mica, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxide)

    Refer to the Package LabelForme Delicious Lip Balm SPF 12-3.2g-Primary Package Label


  • PRINCIPAL DISPLAY PANEL

    Forme

    Delicious Lip Balm

    Vanilla

    Protect SPF 12

    Stop Use if rash occurs.

    Made In Italy- Distributed by Forme Cosmetics, 3600
        S. Congress Ave Suite C, Boynton Beach, FL 33426
    Forme Delicious Lip Balm SPF 12-3.2g-Primary Package Label

  • INGREDIENTS AND APPEARANCE
    FORME COSMETICS DELICIOUS LIP BALM SPF 12 
    titanium dioxide, octinoxate, avobenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.04128 g  in 3.2 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.048 g  in 3.2 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.192 g  in 3.2 g
    Inactive Ingredients
    Ingredient NameStrength
    Lactic Acid (UNII: 33X04XA5AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49825-070-013.2 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/22/2009
    Labeler - CHROMAVIS SPA (338561621)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHROMAVIS SPA338561621manufacture

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