Label: SUNSCREEN SPF50- avobenzone , homosalate , octisalate , oxybenzone , octocrylene 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 June 22, 2018

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  • PURPOSE

    Sunscreen

    Uses

    ● helps prevent sunburn

    ● if used as directed with other sun protection measures

    • decreases the risk of skin cancer and early skin aging caused by the sun 
  • Active ingredients

    Avobenzone 3%, Homosalate 11.7%,
    Octisalate 4.5%, Oxybenzone 5.4%,
    Octocrylene 4.5%

  • Directions 

    ● apply generously 15 minutes before sun exposure

    ● ensure complete coverage to the are above the lip, nose, and tops of ears

    ● reapply: - after 80 minutes of swimming or sweating – immediately after towel drying – at least every 2 hours.

  • WARNING AND Pracaution

    ●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.

    ●If rash occurs, stop use and ask a doctor 

  • ASK DOCTOR SECTION

    ●If rash occurs, stop use and ask a doctor

  • KEEP OUT OF REACH OF CHILDREN SECTION

    • KEEP OUT OF REACH OF CHILDREN SECTION
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • INACTIVE INGREDIENT

    ingredients: water, propylene glycol,
    polyurethane-34, cetyl alcohol, potassium cetyl
    phosphate, glycerin, sorbitan mono stearate,
    polysorbate 60, phenoxyethanol,
    ethylhexylglycerin, potassium hydroxide,
    dimethicone, tocopheryl acetate, acrylates/C10-
    30 alkyl acrylate crosspolymer, arginine, sodium
    ascorbyl phosphate, disodium EDTA

  • Product Label 

    front imagedrug facts

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN  SPF50
    avobenzone , homosalate , octisalate , oxybenzone , octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72376-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE117 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE54 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE45 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Propylene glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)  
    Cetyl alcohol (UNII: 936JST6JCN)  
    Potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitan monostearate (UNII: NVZ4I0H58X)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Potassium hydroxide (UNII: WZH3C48M4T)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    Arginine (UNII: 94ZLA3W45F)  
    Sodium ascorbyl phosphate (UNII: 836SJG51DR)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72376-001-0151 g in 1 BOTTLE; Type 0: Not a Combination Product06/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/11/2018
    Labeler - SKIN KIDZ CC (538908603)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKIN KIDZ CC538908603manufacture(72376-001)
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