Label: BALANCE DYNAMICS BALANCING SPF 15- octisalate oxybenzone octinoxate lotion

  • 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, 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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