BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]

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  • BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]

BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]
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NDC 68828-150-12, 68828-150-17, 68828-150-62
Set ID 31066ffd-d8be-4390-bc91-268162945de9
Category HUMAN OTC DRUG LABEL
Packager JAFRA COSMETICS INTERNATIONAL
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

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

    PURPOSE: SUNSCREEN

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: WATER/AQUA, TRIBEHENIN PEG-20 ESTERS, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, CENTELLA ASIATICA EXTRACT, WITHANIA SOMNIFERIA EXTRACT, BUTYLENE GLYCOL, DIMETHICONE, DIMETHICONE CROSSPOLYMER, XYLITOL, XYLITAN, XYLITYL POLYGLUCOSIDE, GLYCERYL STEARATE, BIS-DIGLYCERYL POLYACRYLADIPATE-2, IRIS FLORENTINA ROOT EXTRACT, RETINYL PALMITATE, ZINC SULFATE, ALCOHOL, PROPYLENE GLYCOL, BIOSACCHARIDE GUM-1, LAMINARIA SACCHARINA EXTRACT, GLYCERIN, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, SILANEDIOL SALICYLATE, ACRYLATES COPOLYMER, CYCLOMETHICONE,  TRIETHANOLAMINE, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, BIOSACCHARIDE GUM-4, PANTHENOL, TOCOPHERYL  ACETATE, CARBOMER, XANTHAN GUM, FRAGRANCE/PARFUM, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID, ZINGIBER OFFICINALE (GINGER) EXTRACT, BISABOLOL, YELLOW 6/CI 15985, RED 33/CI 17200 [FRAGRANCE/PARFUM CONTAINS: AMYL CINNAMAL, BENZYL ALCOHOL, BENZYL BENZOATE, LIMONENE, LINALOOL, BUTYLCHEMYL METHYLPROPIONAL (LILLIAL)].

  • INDICATIONS & USAGE

    BALANCING LOTION SPF 15

  • DOSAGE & ADMINISTRATION

    TO USE: IN THE MORNING AFTER CLEANSING, SMOOTH OVER FACE AND THROAT.

  • WARNINGS

    DISCONTINUE USE IF IRRITATION OCCURS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    BALANCE

    DYNAMICS

    BALANCING LOTION SPF 15

    Balancing Dynamics_ART_BOX-FR_50mLBalancing Dynamics_ART_BOX-BK_50mLBalancing Dynamics_ART_BOX-S1_50mLBalancing Dynamics_ART_BOX-S2_50mLBalancing Dynamics_ART_LBL-FR_50mLBalancing Dynamics_ART_LBL-BK_50mLBalancing Dynamics_ART_LBL-FR_7mLBalancing Dynamics_ART_LBL-BK_7mLBalancing Dynamics_ART_INSERT_7mL

  • INGREDIENTS AND APPEARANCE
    BALANCE DYNAMICS BALANCING  SPF 15
    octisalate oxybenzone octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
    IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XYLITOL (UNII: VCQ006KQ1E)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIGLYCERIN (UNII: 3YC120743U)  
    IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    SILANETRIOL (UNII: E52D0J3TS5)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    GINGER (UNII: C5529G5JPQ)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-150-177 mL in 1 TUBE
    2NDC:68828-150-121 in 1 BOX
    2NDC:68828-150-6250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/24/2012
    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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