Label: RENOVATING REGENERATING MOISTURIZING CREAM- glycerin 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.

  • ASK DOCTOR

    Stop use and ask a doctor if rash occurs

    Children under 6 months: ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

    . keep out of reach of children

  • Questions or Comments?

    Questions or comments? + 34 961 501 099 M-F 9:00 am to 5:00 pm

  • OTHER SAFETY INFORMATION

    . keep the product in a cool and dry place

  • Directions

    . apply every day gently onto clean face and neck

    . can be used in the morning and/or night

  • DOSAGE & ADMINISTRATION

    . apply every day gently onto clean dace and neck

    . can be used in the morning and/or night

  • Uses

    . helps to prevent dehydration of the skin.

    . helps maintain the hydrolipidic layer of the skin

  • INACTIVE INGREDIENT

    Water, Cetyl acetate, Avocado oil, Macadamia integrifolia seed oil, Glyceryl stearate, Egg yolk extract, Triethanolamine, Propylene glycol, Phenylbenzimidazole sulfonic acid, 4-methylbenzylidene camphor, Acetylated lanolin alcohol, Phenoxyethanol, Lecithin, Cetyl phosphate, Carbomer, Corn oil, Chestnut seed extract, Lactic acid, Glycolic acid, Tetrasodium glutamate diacetate, Ethylhexylglycerin, Fragrance, Rosa moschata seed oil, Sodium chloride, BHT, Lysine hydrochloride, Glycine, Caprylyl glycol, Sodium hyaluronate, Arginine, Alanine, Mallow extract, Citric acid, Proline, Ascorbyl palmitate, Acetyl hexapeptide-8, Tocopherol,Potassium sorbate, sodium benzoate, Rosemary leaf extract, Sunflower seed oil, Tricalcium phosphate

  • PURPOSE

    . helps to prevent dehydration of the skin

    . helps maintain the hydrolipidic layer of the skin

  • Active Ingredients

    Glycerin 7.80%........................... Skin Protectant

    Bottle

  • PRINCIPAL DISPLAY PANEL

    Renovating

    Regenerating Moisturizing Cream

    Skin Protectant

    Moisturizing

    RGnerin Hydro Texture

    Facial Collection

    bOX

  • INGREDIENTS AND APPEARANCE
    RENOVATING REGENERATING MOISTURIZING CREAM 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-086
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SPANISH CHESTNUT (UNII: 2MT5XMR2YW) 0.4 mg  in 1 mL
    ROSA MOSCHATA OIL (UNII: J99W255AWF) 0.062 mg  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.03 mg  in 1 mL
    GLYCOLIC ACID (UNII: 0WT12SX38S) 0.21 mg  in 1 mL
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.02 mg  in 1 mL
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) 0.02 mg  in 1 mL
    GLYCINE (UNII: TE7660XO1C) 0.02 mg  in 1 mL
    ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.0023 mg  in 1 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.0015 mg  in 1 mL
    ROSEMARY (UNII: IJ67X351P9) 0.0012 mg  in 1 mL
    CETYL PHOSPHATE (UNII: VT07D6X67O) 0.875 mg  in 1 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.101 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 61.36 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.93 mg  in 1 mL
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.103 mg  in 1 mL
    TOCOPHEROL (UNII: R0ZB2556P8) 0.002 mg  in 1 mL
    PERFLUNAFENE (UNII: 54A06VV62N) 0.1 mg  in 1 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.0015 mg  in 1 mL
    TROLAMINE (UNII: 9O3K93S3TK) 1.7 mg  in 1 mL
    DIPROPYLENE GLYCOL (UNII: E107L85C40) 1.5 mg  in 1 mL
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.875 mg  in 1 mL
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666) 0.0001 mg  in 1 mL
    ARGININE (UNII: 94ZLA3W45F) 0.01 mg  in 1 mL
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.1 mg  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.007 mg  in 1 mL
    PROLINE (UNII: 9DLQ4CIU6V) 0.005 mg  in 1 mL
    CETYL ACETATE (UNII: 4Q43814HXS) 7.83 mg  in 1 mL
    AVOCADO OIL (UNII: 6VNO72PFC1) 4 mg  in 1 mL
    MACADAMIA OIL (UNII: 515610SU8C) 3.99 mg  in 1 mL
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P) 1.17 mg  in 1 mL
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.5 mg  in 1 mL
    ALANINE (UNII: OF5P57N2ZX) 0.01 mg  in 1 mL
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5) 0.009 mg  in 1 mL
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) 0.002 mg  in 1 mL
    CORN OIL (UNII: 8470G57WFM) 0.4375 mg  in 1 mL
    SUNFLOWER OIL (UNII: 3W1JG795YI) 0.0012 mg  in 1 mL
    LACTIC ACID (UNII: 33X04XA5AT) 0.27 mg  in 1 mL
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 2.8 mg  in 1 mL
    EGG YOLK (UNII: 4IPS17B70T) 2.8 mg  in 1 mL
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.022 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-086-021 in 1 BOTTLE, DISPENSING02/23/2017
    1NDC:20151-086-0150 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package
    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(20151-086)