Label: SUNBAR SPF 48- ensulizole homosalate octinoxate octocrylene zinc oxide 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 September 29, 2010

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  • ACTIVE INGREDIENT

    Active ingredients:

    Ensulizole 3%

    Homosalate 10%

    Octinoxate 7.5%

    Octocrylene 7%

    Zinc oxide 8%

  • PURPOSE

    Purpose: Sunscreen
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of children’s reach.
  • INDICATIONS & USAGE

    A hydrating, broad spectrum UVA/UVB sunscreen, which provides protection against sunburn. Combines our moisturizing Bio-MapleTM compound with a mixture of sunscreens that protect skin by scattering, reflecting and absorbing harmful sun rays. Fragrance, color and oil-free, ideal for those with sensitive skin.

    Uses

    ■ Helps prevent sunburn.

    ■ Higher SPF gives more sunburn protection.

    ■ Provides high protection against sunburn.

  • WARNINGS

    Warnings

    For external use only.

    Avoid contact with eyes when using this product. If contact occurs, rinse abundantly with water to remove.

    Discontinue use in case of excessive skin irritation or if condition does not improve. If irritation persists, consult a health care practitioner.

    If swallowed, seek medical assistance or contact a Poison Control Center immediately.


    Other information

    Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

    Store at room temperature 15-30°C (59-86°F).


  • DOSAGE & ADMINISTRATION

    Directions

    ■ Apply liberally and evenly to face and exposed areas 15-30 minutes before sun exposure.

    ■ Reapply every two hours or as needed.

    ■ Reapply after swimming, towel drying, washing or perspiring heavily.

    ■ Consult a doctor before using on children under six months of age.

  • INACTIVE INGREDIENT

    Inactive ingredients: water, cyclopentasiloxane, dimethiconol, acer saccharum (maple isolate), glycerin, cyclohexasiloxane, cetearyl alcohol, steareth-100, polyacrylamide, C13-14 isoparaffin, laureth-7, steareth-2, dimethicone, VP/eicosene copolymer, lactic acid, sodium hydroxide, dimethoxydiphenylsilane/triethoxycaprylylsilane crosspolymer, tocopheryl acetate, xanthan gum, phenoxyethanol, chlorphenesin.
  • PRINCIPAL DISPLAY PANEL

    B. KAMINS

    SUNBAR SPF48


    120 mL / 4 fl. oz
    DIN 02280329
    Sunbar SPF front panel image

  • INGREDIENTS AND APPEARANCE
    SUNBAR SPF 48 
    ensulizole homosalate octinoxate octocrylene zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-809
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ACER SACCHARUM SAP (UNII: 75UOH57984)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    STEARETH-2 (UNII: V56DFE46J5)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63550-809-10120 mL in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/29/2010
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Kamins Dermatologics Inc. (254050784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kamins Dermatologics Inc.254050784manufacture, pack, label
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