Label: SUNBAR SPF 30- avobenzone octinoxate oxybenzone titanium dioxide 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 October 15, 2010

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  • ACTIVE INGREDIENT

    Active ingredients:

    Avobenzone 2.5%

    Octinoxate 7.5%

    Oxybenzone 6%

    Titanium dioxide 2%

  • PURPOSE

    Purpose: Sunscreen
  • KEEP OUT OF REACH OF CHILDREN

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

    This oil and fragrance-free broad spectrum UVA/UVB sunscreen provides important protection against the sun’s harmful rays. Recommended for use on face and body, for everyday wear and outdoor activities. This cosmetically elegant formula is non-greasy, leaves a matte finish, and can be reapplied over makeup.

    • fragrance-free • oil-free
    • for face and body

    Uses

    ■ Helps prevent sunburn.

    ■ Higher SPF gives more sunburn protection.

    ■ Provides high protection against sunburn.

  • WARNINGS

    Warnings

    For external use only.

    When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    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.

    ■ Children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients: water, octyldodecyl neopentanoate, propylene glycol, acer saccharum, tocopheryl acetate, cetyl alcohol, stearic acid, DEA-cetyl phosphate, panthenol, dimethicone, xanthan gum, carbomer, sodium hydroxide, phenoxyethanol, chlorphenesin, BHT, iron oxides (CI 77491).
  • PRINCIPAL DISPLAY PANEL

    B. KAMINS

    SUNBAR SPF30

    120 mL / 4 fl. oz
    DIN 02241810
    SunbarSPF front panel image

  • INGREDIENTS AND APPEARANCE
    SUNBAR SPF 30 
    avobenzone octinoxate oxybenzone titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-811
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ACER SACCHARUM SAP (UNII: 75UOH57984)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63550-811-10120 mL in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/15/2010
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Kamins Dermatologics Inc. (254050784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kamins Dermatologics Inc.254050784manufacture, pack, label
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