Label: LBEL- octinoxate, octisalate, and oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 6, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    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

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

    L'BEL

    HYDRA CALME

    SPF 15
    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 TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.04 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.04 g  in 1 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)  
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-400-021 in 1 BOX
    1NDC:14783-400-0150 mL in 1 TUBE
    2NDC:14783-400-041 in 1 BOX
    2NDC:14783-400-035 mL in 1 TUBE
    3NDC:14783-400-051 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/01/2011
    Labeler - Ventura International Ltd. (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star, S.A.880160197MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Yobel Supply Chain Management S.A.934116930MANUFACTURE
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