Label: ADVANCED DYNAMICS SOOTHING DAY MOISTURE BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream

  • NDC Code(s): 68828-181-01, 68828-181-02, 68828-181-03, 68828-181-04, view more
    68828-181-05, 68828-181-06
  • Packager: Jafra Cosmetics International Inc
  • 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 October 29, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients       Purpose

    Avobenzone 2.5%      Sunscreen

    Octinoxate 6.5%        Sunscreen

    Octisalate 4%            Sunscreen

    Octocrylene 2.75%    Sunscreen

    Oxybenzone 2%        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

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

    Stop use and ask a doctor if rash occurs

    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.

    Directions
     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: 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

    Water/Aqua, PEG-8 Beeswax/Cera Alba, Glyceryl Stearate, Dimethicone, Butyl Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Caprylic/Capric Triglyceride, Glycerin, Cetyl Alcohol, Ceteth-20, Steareth-20, Sodium PCA, Cetyl Alcohol, Butyrospermum Parkii (Shea Butter) Fruit, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Dimethicone Crosspolymer, Saccharide Isomerate, Hydrogenated Avocado Oil, Hemidesmus Indicus Extract, Phyllanthus Emblica Extract, Glycyrrhiza Glabra (Licorice) Extract, Butylene Glycol, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Avena Sativa (Oat) Kernel Extract Glycolipids, Soybean Phytosterols, Sodium Hyaluronate, Panthenol, Tocopheryl Acetate, Ethylhexylglycerin, Methylisothiazolinone, Trisodium EDTA, Cistus Incanus Extract, Maltodextrin

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  • PRINCIPAL DISPLAY PANEL

    carton

    Jafra Advanced Dynamics Soothing Day Moisture Broad Spectrum SPF 15

    with Advanced Intellishield+

    for sensitive skin

    50 ml 1.7 FL OZ

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  • INGREDIENTS AND APPEARANCE
    ADVANCED DYNAMICS SOOTHING DAY MOISTURE BROAD SPECTRUM SPF 15  JAFRA
    avobenzone, octinoxate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-181
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.75 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)  
    HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    LICORICE (UNII: 61ZBX54883)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    OAT (UNII: Z6J799EAJK)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    CISTUS INCANUS FLOWERING TOP (UNII: N7Z341R6CA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-181-02 1 in 1 CARTON 11/26/2013
    1 NDC:68828-181-01 50 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2 NDC:68828-181-04 1 in 1 CARTON 11/26/2013
    2 NDC:68828-181-03 7.5 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3 NDC:68828-181-06 1 in 1 CARTON 11/26/2013
    3 NDC:68828-181-05 2 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 11/26/2013
    Labeler - Jafra Cosmetics International Inc (041676479)
    Registrant - Jafra Cosmetics International Inc (041676479)
    Establishment
    Name Address ID/FEI Business Operations
    Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-181)
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