Label: SUNSPRAY- avobenzone, homosalate, octinoxate, octisalate, titanium dioxide spray

  • 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 January 27, 2015

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  • Active ingredients

    Avobenzone (3.0%), Homosalate (5.0%), Octinoxate (7.5%), Octisalate (6.5%), Titanium Dioxide (2.0%).

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Water, Zemea Propanediol.

  • Keep out of reach of children

    Keep out of reach of children.

  • Directions

    Apply liberally 15 minutes before sun exposure

    Do not spray directly on face

    Reapply ater 80 minutes of swimming or sweating, immediately after towel drying, at least ever 2 hours

    Children under 6 months ask a doctor

  • Use

    Helps prevent sunburn

  • Purpose

    sunscreen

  • Warnings

    Do not use on damaged or broken skin

    Stop use and ask doctor if rash occurs

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

    If swallowed get medical help or contact a poison control center right away

  • Package display

    image

  • INGREDIENTS AND APPEARANCE
    SUNSPRAY 
    avobenzone, homosalate, octinoxate, octisalate, titanium dioxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-218
    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) HOMOSALATE5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE6.5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    DAUCUS CAROTA SUBSP. CAROTA WHOLE (UNII: Q5AR3Y25MQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EUCALYPTUS GUNNII LEAF OIL (UNII: 45P837MS5Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65364-218-01100 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2015
    Labeler - Kiss My Face, LLC (041794279)
    Registrant - Kiss My Face, LLC (041794279)
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