Label: BO SPF15- avobenzone, octinoxate 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 27, 2013

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    Avobenzone 3.00%
    Octinoxate 7.50%

  • Use

    • Helps prevens sunburn
    • If used as direced with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin again caused by the sun.
  • Warnings

    • For external use only
    • Do not use on damaged or broken skin
    • When using this product keep out of eyes. Rinse with water to remove
    • Stop use and ask a docor if rash occurs
    • Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use water resistant sunscreen if swimming or sweathing
    • Reapply at least every 2 hours
    • Children under 6 months: ask a doctor
    • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun especially from 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
  • Inactive Ingredients

    Water (Aqua), Butylene Glycol, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Hydrogenated Vegetable Oil, Glyceryl Stearate, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, Oligopepetide-68, Butyrospermum Parkii (Shea) Buter, Theobroma Cacao (Cocoa) Seed Buter, Diethylhexyl Syringylidenemalonate, Ethylhexylglycerin, Coco-Glucoside, Ammonium Acryloyldimethyltaurate/VP Copolyner, Crambe Abyssinica Seed Oil, Olea Europaea (Olive) Fruit Oil, Hydrogenated Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Panthenol, Citrus Unshiu Peel Extract, Nymphaea Alba Flower Extract, Glycerin, Undecylenoyl Phenylalanine, Sodium Palmitoyl Proline, Ceteth-20, PEG-75 Stearate, Sodium Oleate, Steareth-20, Carbomer, Sodium Hydroxide, Disodium EDTA, o-Cymen-5-ol, Phenoxyethanol, Fragrance (Parfum)

  • Other Information

    Protect this product form excessive heat and direct sun

  • Principal Display Panel

    59735-100-01

  • INGREDIENTS AND APPEARANCE
    BO SPF15 
    avobenzone, octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)  
    CETETH-20 (UNII: I835H2IHHX)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    SODIUM OLEATE (UNII: 399SL044HN)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-100-0175 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/27/2013
    Labeler - Mana Products (078870292)
    Registrant - Mana Products (078870292)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mana Products078870292manufacture(59735-100)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!