Label: LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL- octinoxate, octisalate, oxybenzone lotion

  • 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 March 25, 2012

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

  • L'BEL HYDRA CALME SPF 15 Intensive Moisturizing Facial Lotion


  • Active Ingredients

    Octinoxate  (7.5%),
    Octisalate  (4%),
    Oxybenzone (4%)

  • Uses

    • Helps prevent sunburn
  • Warnings

    • Skin Cancer / Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    • For external use only.

    Do not use

    on damaged or broken skin.

    When using this product

    keep out of eyes.  Rinse with water to remove.

    Stop use and ask a doctor if

    rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Use in the morning after cleansing and toning.  Apply small amounts using the fingertips and spreading with upward, circular movements.  Rub gently until absorbed completely.
    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 years
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age:  Ask a doctor.
  • Other information

    Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    Aqua (water), c12-15 alkyl benzoate, pisum sativum extract (pisum sativum (pea) extract), cyclohexasiloxane, dimethicone, butylene glycol, cetearyl alcohol, erythritol, hdi/trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate / acryloyldimethyl-taurate / dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, glyceryl stearate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, propylene glycol, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, parfum (fragrance), c14-22 alcohols, cetearyl glucoside, butylparaben, cyclopentasiloxane, chlorphenesin, xanthan gum, propylparaben, acrylates/c10-20 alkyl acrylate crosspolymer, disodium edta, sorbic acid, polysorbate 60, c12-20 alkyl glucoside, glycerin, hydrolyzed algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, homarine hcl, rubus chamaemorus fruit extract.

  • Purpose

    Sunscreen
  • EXPERT ROUTINE L'BEL

    L'Bel presents Expert Routine, a skin care program with two steps that work together for enhanced results:

    1. Cleanse the skin according to its needs
    2. Nourish according to the age.
    HYDRA CALME
    Intensive moisturizing line

    To help protect the skin against dehydration, tightness, roughness, dullness and loss of vitality.  L'Bel presents the Hydra Calme Intensive Moisturizing Line.  A miracle of maximum moisturization and comfort for all ages and skin types.

    A new skin care concept whose extraordinary revitalizing and comforting action inundates the skin with a pleasant feeling of freshness, softness and wellbeing to protect it and recover its appearance of beauty and youthfulness.

    The fountain of youth the skin needs every day
    Hydra Calm Intensive Moisturizing Line offers immediate and prolonged moisturization to the areas of the face that need it most.  Its exclusive formulas reestablish the skin's hydric balance and facilitate the transportation of water according to the skin's moisturization needs.

    A discover that changed the concept of moisturization
    An innovative discovery in the world of cosmetic technology: Hydra Comfort Systeme.  A powerful moisturizing complex based on Arctic Berry Extract, an exceptional source of carbohydrates, vitamins, minerals and antioxidants with comforting and softening properties.

    Two formulas for all ages and skin types,  both with a soft, comforting texture and rapid absorption properties:

    1. Intensive moisturizing facial lotion SPF 15

    USES:
    Helps prevent sunburn.  Higher SPF gives more sunburn protection.  Provides moderate protection against sunburn.

    WARNINGS:  For external use only.   When using this product keep out of eyes.  Rinse with water to remove.  Stop use and ask a doctor if rash and irritation develops and lasts.  Keep out of reach of children.   If swallowed, get medical help or contact a Poison Control Center right away.

     Directions:  Apply smoothly every morning before sun exposure and as needed.  Use in the morning after cleansing and toning.  Apply small amounts using fingertips and spreading with upward circular movements.  Rub gently until absorbed completed.  Children under 6 months of age:  ask a doctor.  Moderate sun protection product.

    Other Information:
    • Sun alert:  Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.
    • HYPOALLERGENIC
    • DERMATOLOGICALLY TESTED
    2.  Intensive moisturizing facial cream gel

    USE: 
    Use in the morning and / or at night after cleansing and toning.  Apply small amounts using the fingertips and spreading with upward, circular movements.  Rub gently until absorbed completely.

    WARNING:  For external use only.  Keep out of eyes.  Rinse with water to remove.  Stop use and ask a doctor if Rash and irritation develops and lasts.  Keep out of reach of children.  If swallowed get medical help.
    •  HYPOALLERGENIC
    • DERMATOLOGICALLY TESTED

  • PRINCIPAL DISPLAY PANEL

    L'BEL  HYDRA CALME FPS 15  intensive moisturizing facial lotion SPF 15  50 ml e (1.6 fl.oz.)

    US: Dist. by Ventura International Ltd.  DBA Belcorp USA, San Francisco, CA 94111

    P.R. Dist. by Ventura Corporation Ltd., San Juan, Puerto Rico 00926  MADE IN FRANCE
  • L'BEL HYDRA CALME SPF 15 Intensive Moisturizing Facial Lotion


    Hydra Calme 50ml A


    Hydra Calme 50ml B

    Hydra Calme 50ml C

  • INGREDIENTS AND APPEARANCE
    LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL 
    octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PEA (UNII: W4X7H8GYFM)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ERYTHRITOL (UNII: RA96B954X6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    C20-22 ALCOHOLS (UNII: O4M0347C6A)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBIC ACID (UNII: X045WJ989B)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
    RUBUS CHAMAEMORUS FRUIT (UNII: 74CW8G72Q6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0002-01 mL in 1 POUCH
    2NDC:43596-0002-13 mL in 1 TUBE
    3NDC:43596-0002-230 mL in 1 JAR
    4NDC:43596-0002-350 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/25/2012
    Labeler - Ventura Corporation, LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    MF Productions266769145manufacture