Label: CONTROL DYNAMICS MATTIFYING SPF 15- octinoxate octisalate oxybenzone 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, AZADIRACHTA INDICA EXTRACT, TAGETUS ERECTA (AFRICN MARIGOLD) EXTRACT, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, BUTYLENE GLYCOL, ALUMINUM STARCH OCTENYLSUCCINATE, SODIUM POLYACRYLATE, HYDROGENATED POLYDECENE, TRIDECETH-6, LYSINE CARBOXYMETHYL CYSTEINATE, LYSINE THIAZOLIDINE CARBOXYLATE, DECAMETHYLCYCLOPENTASILOXANE, SACCHARIDE ISOMERATE, MALIC ACID, HYDROLYZED PRUNUS AMGDALUS DULCIS (SWEET ALMOND) PROTEIN, PANTHENOL, PROPYLENE GLYCOL, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, BIOSACCHARIDE GUM-4, BUTYL AVOCADATE, CHONDRUS CRISPUS, (CARRAGEENAN) EXTRACT, TOCOPHERYL ACETATE, FRAGRANCE/PARFUM, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID, ZINGIBER OFFICINALE (GINGER) EXTRACT, BISABOLOL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, POLYSORBATE 20, ETHOXYLATED CASTOR OIL, BLUE 1/CI 42090, YELLOW 5/CI 19140 [FRAGRANCE/PARFUM CONTAINS: BUTYLPHENYL METHYLPROPIONAL (LILLIAL), COUMARIN,  LIMONENE, LINALOOL, HEXYL CINNAMAL]

  • INDICATIONS & USAGE

    MATTIFYING LOTION SPF 15

  • INSTRUCTIONS FOR USE

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

  • WARNINGS

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

  • STOP USE

    DISCONTINUE USE IF IRRITATION OCCUR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    JAFRA

    CONTROL DYNAMICS


    MATTIFYING LOTION SPF 15

    Control Dynamics SPF-15 ART_50mL-Box-FRControl Dynamics SPF-15 ART_50mL-Box-BKControl Dynamics SPF-15 ART_50mL-Box-S1Control Dynamics SPF-15 ART_50mL-BTL-FRControl Dynamics SPF-15 ART_50mL-BTL-BKControl Dynamics SPF-15 ART_7mL-Box-FRControl Dynamics SPF-15 ART_7mL-Tube-FRControl Dynamics SPF-15 ART_7mL-Tube-BK




      


      

  • INGREDIENTS AND APPEARANCE
    CONTROL DYNAMICS MATTIFYING  SPF 15
    octinoxate octisalate oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-158
    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)  
    AZADIRACHTA INDICA BARK (UNII: G580B439YI)  
    TAGETES ERECTA FLOWER (UNII: UH5X33P33E)  
    IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    CYSTEINE, DL- (UNII: 5CM45Q5YAF)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    MALIC ACID (UNII: 817L1N4CKP)  
    ALMOND (UNII: 3Z252A2K9G)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    PERSEA AMERICANA LEAF (UNII: 8490RQ2BET)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    GINGER (UNII: C5529G5JPQ)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYOXYL 60 CASTOR OIL (UNII: VXP26NM2XX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-158-121 in 1 BOX
    1NDC:68828-158-6250 mL in 1 BOTTLE
    2NDC:68828-158-271 in 1 BOX
    2NDC:68828-158-177 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/14/2012
    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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