Label: SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS- octinoxate octisalate oxybenzone stick

  • 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 March 23, 2011

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  • ACTIVE INGREDIENT

    Octinoxate (Octyl Methoxycinnamate) à 7.5 % w/w, Octisalate (Octyl Salicylate) à 3% w/w, Oxybenzone à 3% w/w.

    Inactive ingredients

    RICINUS COMMUNIS (CASTOR) SEED OIL • LANOLIN OIL • OCTYLDODECANOL • RED PETROLATUM • ISOPROPYL PALMITATE • OZOKERITE • EUPHORBIA CERIFERA (CANDELILLA) WAX / CIRE DE CANDELILLA • BEESWAX / CIRE D’ABEILLE • COPERNICA CERIFERA (CARNAUBA) WAX / CIRE DE CARNAUBA • TOCOPHERYL ACETATE • BISABOLOL • PANTHENOL • TOCOPHEROL • ZEA MAYS (CORN) OIL • VEGETABLE OIL / HUILE VEGETALE • GLYCERYL OLEATE • BETA-CAROTENE • PROPYLENE GLYCOL • TBHQ • CITRIC ACID • ISOPROPYLPARABEN • ISOBUTYLPARABEN • BUTYLPARABEN •

    Helps protect from sunburn.Formulated to minimize allergic risks.

    Apply liberally and evenly 15 to 30 minutes before exposure to the sun.Reapply every 2 hours and after swimming perspiring heavily.

  • PRINCIPAL DISPLAY PANEL

    image of cartridge label
    image of cartridge label
    image of carton label

    image of carton label


    For external use only.Keep out of children. Avoid direct contact with the eyes. Stop use if signs of rash or irritation appear.Children under 6 months, ask doctor.

  • INGREDIENTS AND APPEARANCE
    SPF 15 PROTECTIVE BALM WITH UVA/UVB SUNSCREENS 
    octinoxate octisalate oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62499-420
    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) OCTISALATE3 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ACETATE ION (UNII: 569DQM74SC)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    CORN OIL (UNII: 8470G57WFM)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    T-BUTYLHYDROQUINONE (UNII: C12674942B)  
    GLYCERYL MONOOLEATE (UNII: 4PC054V79P)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Colorred (dark red) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62499-420-111 in 1 BOX
    1NDC:62499-420-023.8 g in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/21/2011
    Labeler - Laboratoire Dr Renaud inc. (202501565)
    Registrant - Laboratoire Dr Renaud inc (202501565)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoire Dr Renaud inc202501565manufacture
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