Label: RECOVER SKIN BOOSTING MOISTURIZER BROAD SPECTRUM SPF 15 JAFRA GOLD DYNAMICS- 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 June 7, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients                 Purpose

    Avobenzone 2.5%                  Sunscreen

    Octinoxate 7.5%                     Sunscreen

    Octisalate 4%                         Sunscreen

    Oxybenzone 2%                     Suncreen

  • PURPOSE

    Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measure (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 Contro 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
    • Wehn 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 sunscrren if swimmng or sweating
    • reapply at least every 2 hours
    • 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 a Broad Spectrum SPF 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

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water/Aqua, Cetearyl Alcohol, Ceteareth-20, Glycerin, Stearyl Stearate, Myristyl Myristate, Sodium PCA, Pentylene Glycol, Garcinia Indica Seed Butter, Cyclomethicone, Dimethiconol, Bis-Diglyceryl Polyacyladipate-2, Cetyl Alcohol, Butyrospermum Parkii (Shea Butter) Fruit, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Castanea Sativa (Chestnut) Seed Extract, Carica Papaya Extract, Glycyrrhiza Glabra (Licorice) Extract, Saccharomyces/ Gold Ferment Lysate Filtrate, Fragrance/Parfum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceramide 2, PEG 10 Brassica Campestris Sterol, Palmitoyl Hexapeptide-12, C12-15 Alkyl Benzoate, Tribehenin, Triethanolamine, Panthenol, Citronellol, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Glycine Soja (Soybean) Isoflavone Aglyone, Lecithin, Polysorbate 80, Alcohol, Tocopheryl Acetate, Trisodium EDTA, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Smithsonite Extract, Citonellol, Limonene, Linalool

  • PRINCIPAL DISPLAY PANEL

    Jafra

    Gold dynamics recover

    Skin boosting moisturizer broad spectrum SPF 15

    50 ml    1.7 FL OZ.

    label

  • INGREDIENTS AND APPEARANCE
    RECOVER SKIN BOOSTING MOISTURIZER BROAD SPECTRUM SPF 15  JAFRA GOLD DYNAMICS
    avobenzone, octinoxate, octisalate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARYL STEARATE (UNII: 5WX2EGD0DK)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SPANISH CHESTNUT (UNII: 2MT5XMR2YW)  
    PAPAYA (UNII: KU94FIY6JB)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-202-021 in 1 PACKAGE12/01/2014
    1NDC:68828-202-0150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2014
    Labeler - Jafra Cosmetics International (041676479)
    Registrant - Jafra Cosmetics International (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing814732061manufacture(68828-202)