Label: SPA NIACINAMIDE AND VITAMIN E HAND CREAM BROAD SPECTRUM SPF 15- avobenzone, homosalate, octisalate, octocrylene cream

  • NDC Code(s): 68828-003-01, 68828-003-02
  • Packager: Jafra Cosmetics International Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • Active ingredients

    Avobenzone 3%
    Homosalate 5%
    Octisalate 5%
    Octocrylene 7%

  • 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.

  • Warning

    For external use only
    Do not useon damaged or broken skin
    When using this productkeep out of eyes. Rinse with water to remove.
    Stop use and ask a doctorif rash occurs
    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Direction

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months of age: Ask a doctor
    • 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 your time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

  • KEEP OUT OF REACH OF CHILDREN

  • Inactive ingredients

    Water, Glycerin, Polyester-8, Butyrospermum Parkii (Shea) Butter, Dimethicone, Styrene/Acrylates Copolymer, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Saccharide Isomerate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Isohexadecane, Niacinamide, Hydroxyethyl Urea, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Arginine, Chlorphenesin, Arachidyl Glucoside, Disodium EDTA, Panthenol, Persea Gratissima (Avocado) Oil, Phytosterols, Sorbitan Isostearate, Polysorbate 60, Olea Europaea (Olive) Fruit Oil, Fragrance

  • Other information

    Protect this product from excessive heat and direct sun

  • Product label

    image description
  • INGREDIENTS AND APPEARANCE
    SPA NIACINAMIDE AND VITAMIN E HAND CREAM BROAD SPECTRUM SPF 15 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ARGININE (UNII: 94ZLA3W45F)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-003-011 in 1 CARTON06/01/2022
    175 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68828-003-021 in 1 CARTON06/01/2022
    27 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2022
    Labeler - Jafra Cosmetics International Inc (041676479)
    Registrant - Jafra Cosmetics International Inc (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-003)
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