Label: SELECT BRAND SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, 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 November 21, 2012

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

  • Active ingredients

    Avobenzone 3.0%
    Homosalate 15.0%
    Octisalate    5.0%
    Octocrylene 10.0%
    Oxybenzone 6.0%
  • Purpose

    Sunscreen
  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in water
  • 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 the reach of children.
    If swallowed get medical help or contact a Poison Control Center right away.
  • Directions

    • shake well
    • apply generously and evenly before sun exposure and as needed
    • children under 6 months of age: ask a doctor
    • reapply frequently and after towel drying, swimming or perspiring

    Other information

    • may stain some materials
  • Inactive ingredients

    Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.
  • Principal Display Panel

    select brand
    the lower price name brand
    SUNSCREEN LOTION
    70 SPF
    UVA/UVB
    Photostable
    MOISTURIZING
    Broad Spectrum
    Protection
    VERY WATER RESISTANT
    8 FL OZ(237 mL)
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  • INGREDIENTS AND APPEARANCE
    SELECT BRAND SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-006-16226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/21/2012
    Labeler - Select Brand Distributors (043562370)