Label: DAY CARE FOR HANDS BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, octisalate, oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 5, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients                       Purpose

    Avobenzone 3% ......................... Sunscreen

    Octinoxate 7.5% ......................... Sunscreen

    Octisalate 4% ............................. Sunscreen

    Oxybenzone 2% ......................... Sunscreen

  • PURPOSE

    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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    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.
  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 minths: 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 time in the sun, especially from 10a.m. - 2p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Water/Aqua, Polyglycery-3 Methylglucose Distearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glyceryl Stearate, Glycerin, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Withania Somniferia (Winter Cherry) Extract, Vigna Radiata (Mung Bean) Extract, Trisodium EDTA, Panthenol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Biasacchardie Gum-4, Chondrus Crispus (Carrageenan) Extract, Chamomilla Recutita (Matricaria) Extact, Morus Alba Extract, Lonicera Caprifolium (Honeysuckle) Flower Extract, Potassium Sorbate, Fragrance/Parfum

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    spa

    Day Care for Hands

    Broad Spectrum SPF 15

    with intellishield

    75ml e 2.5 FL OZ (US)

    Box

  • INGREDIENTS AND APPEARANCE
    DAY CARE FOR HANDS BROAD SPECTRUM SPF 15  JAFRA
    avobenzone, octinoxate, octisalate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 75 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 75 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 75 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 75 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-400-021 in 1 BOX06/14/2016
    1NDC:68828-400-0175 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/14/2016
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V814732061manufacture(68828-400)
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