Label: LBEL- octinoxate, octisalate, and oxybenzone 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 August 6, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate (7.5 %), Octisalate (5 %), Oxybenzone (6 %)

  • 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 twice a day before sun exposure and as needed.
    • Reapply as needed or after towel drying, swimming or sweating.
    • Moderate sun protection product.
    • Children under 6 months of age: ask a doctor.
  • 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), cyclohexasiloxane, c12-15 alkyl benzoate, cetearyl alcohol, ethylhexyl stearate, cyclopentasiloxane, citrus unshui peel extract, propylene glycol, triethanolamine, glycerin, dicetyl phosphate, ceteth-10 phosphate, sodium lactate, tocopheryl acetate, phenoxyethanol, diazolidinyl urea, parfum (fragance), glycolic acid, methylparaben, sucrose, urea, sodium citrate, propylparaben, malic acid, tartaric acid, camellia sinensis leaf extract.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

    L'BEL

    CLARIFIQUE
    DERMO RADIANCE
    MAINS SPF 15

    clarifying and illuminating
    treatment hand cream spf 15

    100 g e (3.5 oz.)

    PRINCIPAL DISPLAY PANEL - 100 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    LBEL   CLARIFIQUE DERMO RADIANCE MAINS SPF 15
    octinoxate, octisalate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    tangerine (UNII: KH3E3096OO)  
    propylene glycol (UNII: 6DC9Q167V3)  
    trolamine (UNII: 9O3K93S3TK)  
    glycerin (UNII: PDC6A3C0OX)  
    dihexadecyl phosphate (UNII: 2V6E5WN99N)  
    phosphate ion (UNII: NK08V8K8HR)  
    sodium lactate (UNII: TU7HW0W0QT)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    glycolic acid (UNII: 0WT12SX38S)  
    methylparaben (UNII: A2I8C7HI9T)  
    sucrose (UNII: C151H8M554)  
    urea (UNII: 8W8T17847W)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    propylparaben (UNII: Z8IX2SC1OH)  
    malic acid (UNII: 817L1N4CKP)  
    tartaric acid (UNII: W4888I119H)  
    green tea leaf (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-077-611 in 1 BOX
    1NDC:14783-077-62100 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/15/2010
    Labeler - VENTURA INTERNATIONAL LTD., (603192787)
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