Label: VITALIZING ENERGIZING MOISTURIZING CREAM- glycerin, dimethicone 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 February 23, 2017

If you are a consumer or patient please visit this version.

  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep our of the eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

    Whhen using this product do not get into eyes.

    Children under 6 months: as a doctor.

    WARNINGS

    Stop use and ask a doctor if rash occurs

    Children under 6 months: ask a doctor

    Warnings

    Keep out of reach of children

  • Questions or comments?

    + 34 961 501 999 M-F 9:00 am to 5:00 pm

  • Other Information

    . keep the product in a cool and dry place

  • Directions

    . apply every day gently onto clean face and neck until the product has been absorbed

    . can be used in the morning and/or night

    . apply every day gently onto clean dace and neck until the product has been absorbed

    . can be used in the morning and/or night

  • Uses

    . provides an intensive dose of hydration and energy

  • Inactive Ingredients

    water, cyclopentasiloxane, steareth-21, avocado oil, squalane, PEG-8 distearate, steareth-2, phenoxyethanol, avena sativa (oak) kernel extract, creatine, carbomer, triethanolamine, parfum, ethylhexylglycerin, limonene, ubiquinone, tetrasodium glutamate diacetate, citric acid, sodium citrate, soluble collage, sodium hyaluronate, linalool, sodium benzoate, ascorbyl palmitate

  • Uses

    . provides an intense dose of hydration and energy

  • ACTIVE INGREDIENTS PURPOSE

    Glycerin 5%.................... Skin Protectant

    Dimethicone 0.40%.........Skin Protectant

    Box

  • See below image

    Vitalizing Energizing Moisturizing Cream

    Skin Protectant

    Nourishing

    Intensive Q 10 Hydro 24 h

  • Package Label

    Please see image below. Package Label

    Bottle

  • INGREDIENTS AND APPEARANCE
    VITALIZING ENERGIZING MOISTURIZING CREAM 
    glycerin, dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-089
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3 mg  in 1 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 3 mg  in 1 mL
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.5 mg  in 1 mL
    PEG-8 DISTEARATE (UNII: 7JNC8VN07M) 2 mg  in 1 mL
    STEARETH-2 (UNII: V56DFE46J5) 2 mg  in 1 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 78.27 mg  in 1 mL
    PERFLUNAFENE (UNII: 54A06VV62N) 0.3 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.104 mg  in 1 mL
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
    UBIQUINOL (UNII: M9NL0C577Y) 0.1 mg  in 1 mL
    OAT KERNEL OIL (UNII: 3UVP41R77R) 0.52 mg  in 1 mL
    LINALOOL, (+)- (UNII: F4VNO44C09) 0.019 mg  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.045 mg  in 1 mL
    ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.001 mg  in 1 mL
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W) 0.025 mg  in 1 mL
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.02 mg  in 1 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.0125 mg  in 1 mL
    CREATINE (UNII: MU72812GK0) 0.5 meq  in 1 mL
    AVOCADO OIL (UNII: 6VNO72PFC1) 2.6 mg  in 1 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.027 mg  in 1 mL
    SQUALANE (UNII: GW89575KF9) 2 mg  in 1 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.4 mg  in 1 mL
    STEARETH-21 (UNII: 53J3F32P58) 3 meq  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-089-021 in 1 BOTTLE, DISPENSING02/23/2017
    1NDC:20151-089-0150 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/23/2017
    Labeler - Casmara Cosmetics, SA (464973544)
    Registrant - Casmara Cosmetics, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casmara Cosmetics, SA464973544manufacture(20151-089)