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LBEL (Ventura Corporation Ltd. (San Juan, P.R))

Available Formats

Dosage Form Package Information Links
LOTION 1 TUBE in 1 BOX (13537-031-04) > 5 mL in 1 TUBE (13537-031-03) Label Information
LOTION 1 mL in 1 PACKET (13537-031-05) Label Information
LOTION 1 TUBE in 1 BOX (13537-031-02) > 50 mL in 1 TUBE (13537-031-01) Label Information

Complete LBEL Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active Ingredient Purpose
    Octinoxate 7.5% Sunscreen
    Octisalate 4.0 % Sunscreen
    Oxybenzone 4.0%, Sunscreen

  • 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 or 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 the fingertips and spreading with upward, circular movements. Rub gently until absorbed completely.
    • 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 sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the 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/ acryloyldimethyltaurate/ 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/ c10-30 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


  • SPL UNCLASSIFIED SECTION

    P.R.: Dist by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.


  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

    L'BEL

    HYDRA CALME

    SPF15
    Intensive moisturizing
    face lotion with SPF 15

    50 ml e (1.6 fl.oz.)

    Principal Display Panel - 50 ml Bottle Carton

  • INGREDIENTS AND APPEARANCE
    LBEL   HYDRA CALME SPF 15
    octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-031
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.04 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.04 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    c20-22 alkyl phosphate (UNII: L4VKP0Y7RP)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    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)  
    chlorphenesin (UNII: I670DAL4SZ)  
    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)  
    rubus chamaemorus fruit (UNII: 74CW8G72Q6)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13537-031-02 1 in 1 BOX
    1 NDC:13537-031-01 50 mL in 1 TUBE
    2 NDC:13537-031-04 1 in 1 BOX
    2 NDC:13537-031-03 5 mL in 1 TUBE
    3 NDC:13537-031-05 1 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 08/29/2011
    Labeler - Ventura Corporation Ltd. (San Juan, P.R) (602751344)
    Establishment
    Name Address ID/FEI Business Operations
    Bel Star, S.A. 880160197 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Yobel Supply Chain Management S.A. 934116930 MANUFACTURE