SUNSCREEN SPF50 (AVOBENZONE , HOMOSALATE , OCTISALATE , OXYBENZONE , OCTOCRYLENE) LOTION [SKIN KIDZ CC]

SUNSCREEN SPF50 (AVOBENZONE , HOMOSALATE , OCTISALATE , OXYBENZONE , OCTOCRYLENE) LOTION [SKIN KIDZ CC]
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NDC 72376-001-01
Set ID 9819e603-8a87-408a-839d-e325493590aa
Category HUMAN OTC DRUG LABEL
Packager SKIN KIDZ CC
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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