Label: LBEL- octinoxate, octisalate, and 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 August 10, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

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

  • Purpose

    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 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 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 sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    Aqua (water), c12-15 alkyl benzoate, 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, propyleneglycol, hydroxyethyl acrylate/sodium acryloyldymethyl taurate copolymer, glyceryl stearate, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, parfum (fragance), c14-22 alcohols, cetearyl glucoside, butylparaben, cyclopentasiloxane, chlorphenesin, propylparaben, xanthan gum, disodium edta, acrylates/c10-30 alkylacrilate crosspolymer, sorbic acid, polysorbate 60, c12-20 alkyl glucoside, glycerin, hydrolized algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, homarine hcl, rubus chamaemorus fruit extract.

  • SPL UNCLASSIFIED SECTION

    USA: Distributed by Ventura
    International Ltd, San Francisco,
    CA 94111.

  • PRINCIPAL DISPLAY PANEL - 30 ml Carton

    L'BEL
    PARIS

    HYDRA CALME

    SPF 15

    intensive moisturizing facial
    lotion SPF 15

    30 ml e (1 fl.oz.)

    Principal Display Panel - 30 ml Carton
  • INGREDIENTS AND APPEARANCE
    LBEL   HYDRA CALME
    octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-088
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate2.25 mg  in 30 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate1.2 mg  in 30 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1.2 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    snow pea (UNII: 84SKC33B1I)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    dimethicone (UNII: 92RU3N3Y1O)  
    butylene glycol (UNII: 3XUS85K0RA)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    erythritol (UNII: RA96B954X6)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    trolamine (UNII: 9O3K93S3TK)  
    isohexadecane (UNII: 918X1OUF1E)  
    methylparaben (UNII: A2I8C7HI9T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    chlorphenesin (UNII: I670DAL4SZ)  
    propylparaben (UNII: Z8IX2SC1OH)  
    xanthan gum (UNII: TTV12P4NEE)  
    edetate disodium (UNII: 7FLD91C86K)  
    sorbic acid (UNII: X045WJ989B)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    glycerin (UNII: PDC6A3C0OX)  
    ethylparaben (UNII: 14255EXE39)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-088-631 in 1 BOX
    1NDC:13537-088-6230 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/15/2010
    LBEL   HYDRA CALME
    octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-089
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.04 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.04 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    snow pea (UNII: 84SKC33B1I)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    dimethicone (UNII: 92RU3N3Y1O)  
    butylene glycol (UNII: 3XUS85K0RA)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    erythritol (UNII: RA96B954X6)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    trolamine (UNII: 9O3K93S3TK)  
    isohexadecane (UNII: 918X1OUF1E)  
    methylparaben (UNII: A2I8C7HI9T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    chlorphenesin (UNII: I670DAL4SZ)  
    propylparaben (UNII: Z8IX2SC1OH)  
    xanthan gum (UNII: TTV12P4NEE)  
    edetate disodium (UNII: 7FLD91C86K)  
    sorbic acid (UNII: X045WJ989B)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    glycerin (UNII: PDC6A3C0OX)  
    ethylparaben (UNII: 14255EXE39)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-089-531 in 1 BOX
    1NDC:13537-089-521 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/15/2010
    Labeler - Ventura International LTD (602751344)
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