Label: FACE SPF 50- avobenzone,octinoxate,octocrylene, oxybenzone, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 10, 2019

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  • Drug Facts Active ingredients

    AVOBENZONE 2%

    OCTINOXATE 2%

    OCTOCRYLENE 2%

    OXYBENZONE 2%

    TITANIUM DIOXIDE 2%

  • PURPOSE

    SUNSCREEN

  • USES

    helps prevent sunburn

    use as directed with other sun protection measures (see Direction), decrease the risk of skin cancer and early skin aging caused by the sun

  • WARNINGS

    For external use only

    Do not use on damaged or broken skin

    Stop use and ask doctor if rash occurs

    When using this product, keep put of eyes. Rinse with water to remove

    Keep out of reach of children. If swalloed, get medical help or contact Poison Control Center right away.

  • DIRECTIONS

    apply liberally 15 minutes before sun exposure

    reapply: at least every 2 hours, immediately after towel drying

    use a water-resistant sunscreen if swimming or sweating

    children under 6 months: Ask a doctor

    Sun Protection Measures. Spending time in the sun increases your risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:

    limite the time in the sun, especially from 10 a.m. - 2 p.m.

    wear long-sleeved shirts, pants, hats, and sunglasses

  • INACTIVE INGREDIENTS

    ammonium acryloydimethytaurate-vp copolymer, bis-ethylhexyloxphenol methoxphenyl triazine, BHT, butyrospermum parkii butter extract, caprylic capric triglyceride, carbomer, carthamus, cetearyl alcohol, citronellol,coumarin, diethylhexylsyringylidenemalonate, decyl gluside, diisopropyl sebacate, dimethicone, dimethiconol behenate, c12-15 alkyl benzoate, glycerin, glyceryl stearate, hexyl cinnamal, hydrolyzed soy protein, hydrolyzed wheat protein, limanathes alba seed oil, limonene, linalool, methylene bisbenzotriazolyl tetramethybutyphenol (nano), menthyl lactate, methylisothiazolinone, olea europapea oil unasonifiables, parfum, peg-100 stearate, phenoxyethanol, pseudoalteromonas ferment extract, propylene glycol, tocopherylacetate, triethanolamine, tripeptide-1, tripeptide-10 citrulline, vp-eicosene copolymer, water, xanthan gum

  • OTHER INFORMATION

    Protect this product from excessive heat and direct sun

  • SUNSCREEN LABEL

    sunscreen 5022 spf 50.jpgSUNSCREEN FACE SPF 50 SPRAY 5022

  • INGREDIENTS AND APPEARANCE
    FACE  SPF 50
    avobenzone,octinoxate,octocrylene, oxybenzone, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73310-5022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 mg  in 5 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1 mg  in 5 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 mg  in 5 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1 mg  in 5 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-100 STEARATE (UNII: YD01N1999R) 1 mg  in 5 mL
    Product Characteristics
    Colorwhite (Cream) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73310-5022-250 mL in 1 CONTAINER; Type 0: Not a Combination Product08/28/2019
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/28/2019
    Labeler - AGEFARM SRL (439202467)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMESIT SRL339071951manufacture(73310-5022)
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