Label: HARMONY DYNAMICS FACIAL BOOSTING SPF 15- octinoxate octisalate oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 31, 2012

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  • ACTIVE INGREDIENT

    SUNSCREEN ACTIVE INGREDIENT (SPF 15):
    OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3
  • PURPOSE

    PURPOSE: SUNSCREEN

  • INACTIVE INGREDIENT

    INGREDIENTS: WATER/AQUA, CETEARYL ALCOHOL, CETEARETH-20, GLYCERIN, STEARYL STEARATE, MYRISTYL MYRISTATE, GARCINIA INDICA SEED BUTTER, SODIUM PCA, CYCLOMETHICONE, DIMETHICONOL, PENTYLENE GLYCOL, BIS-DIGLYCERYL POLYACRYLADIPATE-2, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, CASTANEA SATIVA (CHESTNUT) EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) EXTRACT, MORINGA OLIEFERA EXTRACT, VETIVERA ZINZANOIDS (KHUS ROOT) EXTRACT, WITHANIA SOMNIFERIA (WINTER CHERRY) EXTRACT, MENTHA PIPERTITA (PEPPERMINT) EXTRACT, CERAMIDE 2, PEG 10 BRASSICA CAMESTRIS STEROL, PALMITOYL OLIGOPEPTIDE, C12-15 ALKYL BENZOATE, TRIBEHENIN, CETYL ALCOHOL, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, TOCOPHEROL, GLYCEINE SOJA (SOYBEAN) ISOFLAVONE AGLYONE, LECITHIN, POLYSORBATE 80, ALCOHOL, FRAGRANCE/PARFUM, TRIETHANOLAMINE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DMDM HYDANTOIN, PANTHENOL, BIOSACCHARIDE GUM-4, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, PEG-4 LAURATE, IODOPROPYL BUTYLCARBAMATE, TRISODIUM EDTA.



  • DESCRIPTION

    A LUXURIOUS RICH CREAM FOR COMPLEXIONS AFFECTED BY HORMONAL IMBALANCES AND AGING WHICH CAN MAKE THE SKIN DRY AND LACK VITALITY.

  • INDICATIONS & USAGE

    THIS UNIQUE FORMULA HELPS SOOTHE AND SMOOTH THE SKIN WHILE FIGHTING AGAINST SIGNS OF AGING AND CONTAINS A PRO-ENDORPHIN COMPLEX THAT HELPS PROVIDE A PLEASURABLE SENSATION TO THE SKIN, CREATING A VISIBLE APPEARANCE OF REFRESHED, YOUNGER AND MORE RADIANT LOOKING SKIN.

  • INSTRUCTIONS FOR USE

    TO USE: SMOOTH OVER FACE AND THROAT DAY AND NIGHT AFTER CLEANSING.

  • WARNINGS

    CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

  • STOP USE

    DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • OTHER SAFETY INFORMATION

    CLINICALLY, ALLERGY, IRRITANCY AND DERMATOLOGIST TESTED.

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    HARMONY DYNAMICS

    FACIAL BOOSTING CREAM SPF 15

    WITH / CON INTELLISHIELD


    Harmony Dynamics ART_Box-FR   Harmony Dynamics ART_Box-BK   Harmony Dynamics ART_Box-S1   Harmony Dynamics ART_Box-S2

    Harmony Dynamics ART_LBL-FR   Harmony Dynamics ART_LBL-BK


  • INGREDIENTS AND APPEARANCE
    HARMONY DYNAMICS FACIAL BOOSTING  SPF 15
    octinoxate octisalate oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 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)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIGLYCERIN (UNII: 3YC120743U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SPANISH CHESTNUT (UNII: 2MT5XMR2YW)  
    LICORICE (UNII: 61ZBX54883)  
    MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)  
    VETIVERIA ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z)  
    WITHANIA SOMNIFERA LEAF (UNII: J337CNM3CW)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    CAMPESTEROL (UNII: 5L5O665639)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-163-121 in 1 BOX
    1NDC:68828-163-6250 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/19/2012
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture
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